Five Doubts You Should Clarify About Chinese Food Near Me 85281. | chinese food near me 85281

N970003/S1527/25/13Real-Time

[caption id="" align="aligncenter" width="400px"]Little Szechuan | Order Online | Tempe, AZ 85281Little Szechuan | Order Online | Tempe, AZ 85281 | chinese food near me 85281
[/caption]

Advantio, Ingenio, Vitalio, Formio ancestors of Implantable Pulse Generators, Application Software

Boston Scientific Corporation St. Paul, MN 55112

Approval for Model 2869 ZOOMVIEW Programmer Software Appliance v1.09 and Ingenio Firmware adaptation D_v1.02 with Patch v1.01 for the devices.

P790007/S0377/31/13135-Day

Hancock® Adapted Orifice Valved Conduit

Medtronic Heart ValvesSanta Ana, CA 92705

Approval to use two new autoclaves.

P810032/S0637/23/13180-Day

PMMA Multi-Piece Posterior Chamber Intraocular Lenses (IOLs)

Alcon Research, Ltd.Fort Worth, TX 76134

Approval for a accomplishment armpit amid at Alcon Research, Ltd., in Lesage, West Virginia.

P830061/S0937/23/13Real-Time

Adhesive, CapSure Lead, Vitatron Crystalline Lead, Vitatron Excellence PS Lead

Medtronic, Inc. Mounds View, MN 55112

Approval for an access in the accumulator shelf activity of the Tyvek lid component, which includes the adhering coating, acclimated in the Medtronic Cardiac Rhythm Disease Administration articles from 18 months to 48 months.

P840060/S0397/23/13180-Day

PMMA Single-PiecePosterior Chamber IOLs

Alcon Research, Ltd.Fort Worth, TX 76134

Approval for a accomplishment armpit amid at Alcon Research, Ltd., in Lesage, West Virginia.

P850089/S0987/23/13Real-Time

CapSure SP Novus, CapSure SP Z, CapSure Z Novus, Impulse II Leads

Medtronic, Inc. Mounds View, MN 55112

Approval for an access in the accumulator shelf activity of the Tyvek lid component, which includes the adhering coating, acclimated in the Medtronic Cardiac Rhythm Disease Administration articles from 18 months to 48 months.

P870078/S0207/31/13135-Day

Hancock® Porcine Bioprosthesis

Medtronic Heart ValvesSanta Ana, CA 92705

Approval to use two new autoclaves.

P880087/S0217/23/13180-Day

PMMA Anterior Chamber IOLs

Alcon Research, Ltd.Fort Worth, TX 76134

Approval for a accomplishment armpit amid at Alcon Research, Ltd., in Lesage, West Virginia.

P890003/S2777/15/13Real-Time

Synergyst II Pacing System, CareLink Monitors, CareLink Express Monitors, CardioSight Readers

Medtronic, Inc.  Mounds View, MN 55112

Approval for Cellular Connectivity for Remote Monitoring with Model 2020A CardioSight Reader and Models 2020B, 2020C Medtronic CareLink Express Monitors.

P890003/S2787/23/13Real-Time

Synergyst II Pacing System, CapSure Lead, Prodigy IPG, Service Kit-Pacemaker Repair Kit

Medtronic, Inc. Mounds View, MN 55112

Approval for an access in the accumulator shelf activity of the Tyvek lid component, which includes the adhering coating, acclimated in the Medtronic Cardiac Rhythm Disease Administration articles from 18 months to 48 months.

P900061/S1227/23/13Real-Time

7216A PCD

Medtronic, Inc. Mounds View, MN 55112

Approval for an access in the accumulator shelf activity of the Tyvek lid component, which includes the adhering coating, acclimated in the Medtronic Cardiac Rhythm Disease Administration articles from 18 months to 48 months.

P910073/S1187/16/13Real-Time

ENDOTAK Lead System

Boston ScientificSt. Paul, MN 55112

Approval for an alternating album actual for the Acquiescent FixationReliance IS-1/4-SITE leads.

P920015/S1137/23/13Real-Time

Transvene, SQ, Sprint and Sprint Fidelis Lead Models and Accessories

Medtronic, Inc. Mounds View, MN 55112

Approval for an access in the accumulator shelf activity of the Tyvek lid component, which includes the adhering coating, acclimated in the Medtronic Cardiac Rhythm Disease Administration articles from 18 months to 48 months.

P920047/S0587/22/13135-Day

EPT-1000 Cardiac Ablation System

Boston Scientific Corp.San Jose, CA 95134

Approval to move the banishment action for Blazer Prime AblationCatheters to a new accomplishment band introducing an automatic action to analyze and cutmarked sections of the extruded shaft.

P930014/S0667/23/13180-Day

AcrySof IOLs

Alcon Research, Ltd.Fort Worth, TX 76134

Approval for a accomplishment armpit amid at Alcon Research, Ltd., in Lesage, West Virginia.

P930021/S0137/2/13180-Day

Straumann Emdogain

Straumann USAAndover, MA 01810

Approval for a accomplishment armpit amid at Medeon Science Park, in Malmo, Sweden.

P930039/S0897/23/13Real-Time

CapSureFix Lead, CapSureFix Novus Lead, SureFix Lead, Torque Clip Device, Vitatron Crystalline Lead

Medtronic, Inc. Mounds View, MN 55112

Approval for an access in the accumulator shelf activity of the Tyvek lid component, which includes the adhering coating, acclimated in the Medtronic Cardiac Rhythm Disease Administration articles from 18 months to 48 months.

P940035/S0107/16/13Special

NMP22 Analysis Kit (EIA), NMP22 Urine Accumulating KitNMP22, Bladder-Chek Test

Alere Scarborough, Inc.Scarborough, ME 04074

Approval for additions to the Limitations and Precautions sections of the Package Insert.

P950005/S0427/22/13135-Day

Celsius, Celsius RMT, EZ Steer Non-Temp Sensing Ablation Catheters

Biosense Webster, Inc. Diamond Bar, CA 91765

Approval for the alteration of the Grinding Action from Irwindale, California accomplishment ability to Juarez, Mexico accomplishment facility.

P950008/S0107/15/13Special

Silikon™ 1000 (Purified polydimethyl-siloxane)

Alcon Laboratories, Incorporated Fort Worth, TX 76134

Approval for labeling modifications to the Silikon™ 1000 Oil Directions for Use.

P950018/S0167/9/13180-Day

PERFLUORON™ Ocular Endotamponade

Alcon Laboratories, Inc. Fort Worth, TX 76134

Approval for changes to the adhering resins (limonene-based adhering TR7125 has replaced the accepted limonene-based adhering TR1135, and ethylene vinyl acetate adhering UL8705 has replaced the accepted EVA adhering 205W) acclimated for the Tyvek lid and validation of an air-over-steam (AOS) sterilization aeon to adjust practices amid articles aural the accomplishment facility.

P950024/S0507/23/13Real-Time

CapSure Epicardial Pacing Lead

Medtronic, Inc. Mounds View, MN 55112

Approval for an access in the accumulator shelf activity of the Tyvek lid component, which includes the adhering coating, acclimated in the Medtronic Cardiac Rhythm Disease Administration articles from 18 months to 48 months.

P950032/S0727/11/13Real-Time

Apligraf (Graftskin)

Organogenesis, Inc.Canton, MA02021

Approval for the accession of Animal Epidermal Keratinocyte cellstrain 197 (HEP 197) for use in the accomplish of Apligraf, and for approval of a change from the accepted analysis appraisal for apprehension of assertive viral contaminants to a real-time PCR adjustment from a accepted gel-based PCR method.

P950037/S1247/12/13Real-Time

Dromos DR/SR Rate Adaptive Pacing Systems

Biotronik, Inc.6024 Jean Road Lake Oswego, OR 97035

[caption id="" align="aligncenter" width="400px"]Umami, Tempe - Restaurant Reviews, Phone Number Umami, Tempe - Restaurant Reviews, Phone Number | chinese food near me 85281
[/caption]

Approval of the accession of a pacing arrangement analyzer (PSA)module to the Renamic Programmer, as able-bodied as an adapted affectation awning and associatedlabeling updates.

P950037/S1257/30/13Real-Time

Dromos DR/SR Rate Adaptive Pacing Systems

Biotronik, Inc. Lake Oswego, OR 97035

Approval for an alternating separator actual acclimated in the Litronik batteries for the devices.

P960016/S0427/18/13135-Day

Livewire Cardiac Ablation System

St. Jude MedicalMinnetonka, MN 55345

Approval to amend the action ambit in the accomplishment action for a new bang mold.

P970003/S1627/10/13Real-Time

VNS Therapy System

Cyberonics, Inc.Houston, TX 77058

Approval for a change to the Transmit to Receive Refractory Timewhich is a blueprint of the Appliance Specific Integrated Circuit (ASIC) acclimated in Model103/104/105 VNS Generators and the accomplishing of a screening analysis to be performed at thevendor (ON Semiconductor).

P970031/S0417/31/13135-Day

Freestyle® Aortic Root Bioprosthesis

Medtronic Heart ValvesSanta Ana, CA 92705

Approval to use two new autoclaves.

P980016/S4167/15/13Real-Time

Medtronic Implantable Cardioverter Defibrillator Families (GEM, Marquis, Maximo,Intrinsic Onyx, EnTrust, Virtuoso, Secura, Protecta) and Model 6940 CapSureFix Lead

Medtronic, Inc. Mounds View, MN 55112

Approval for Cellular Connectivity for Remote Monitoring with Model 2020A CardioSight Reader and Models 2020B, 2020C Medtronic CareLink Express Monitors.

P980016/S4177/23/13Real-Time

Medtronic Implantable Cardioverter Defibrillator Families (GEM, Marquis, Maximo,Intrinsic Onyx, EnTrust, Virtuoso, Secura, Protecta) and Model 6940 CapSureFix Lead

Medtronic, Inc. Mounds View, MN 55112

Approval for an access in the accumulator shelf activity of the Tyvek lid component, which includes the adhering coating, acclimated in the Medtronic Cardiac Rhythm Disease Administration articles from 18 months to 48 months.

P980022/S1347/8/13Real-Time

Paradigm REAL-Time Revel System

Medtronic MiniMedNorthridge, CA 91325

Approval for software changes to the Paradigm REAL-Time RevelInsulin Pump (MMT-523, MMT-523K, MMT-723, and MMT-723K) appliance software. TheParadigm REAL-Time Revel Insulin Pump is a basic of the Paradigm REAL-Time RevelSystem.

P980023/S0567/30/13Real-Time

Phylax lCD System

Biotronik, Inc.Lake Oswego, OR 97035

Approval for the accessory labeling modifications/corrections, whichincludes an amend of the Indication for Use Statements (IFU) to accommodate the bazaar approveddevices with the aforementioned IFU, and added accessory corrections to the labeling.

P980035/S3257/15/13Real-Time

Kappa 700/600 Series of Pulse Generators, Advisa, EnRhythm MRI,

Medtronic, Inc.  Mounds View, MN 55112

Approval for Cellular Connectivity for Remote Monitoring with Model 2020A CardioSight Reader and Models 2020B, 2020C Medtronic CareLink Express Monitors.

P980035/S3267/17/13Real-Time

Adapta, Versa, Sensia, Relia Implantable Pulse Generators

Medtronic, Inc. Mounds View, MN 55112

Approval for a architecture change to the L386 Integrated Circuit and associated accessory accomplishment changes.

P980035/S3277/23/13Real-Time

Kappa 700/600 Series of Pulse Generators, Adapta, Versa, Sensia, Advisa DR, Advisa DR MRI, Relia Implantable Pulse Generators (IPGs)

Medtronic, Inc. Mounds View, MN 55112

Approval for an access in the accumulator shelf activity of the Tyvek lid component, which includes the adhering coating, acclimated in the Medtronic Cardiac Rhythm Disease Administration articles from 18 months to 48 months.

P980043/S0417/31/13135-Day

Hancock® II Bioprosthetic Heart Valve

Medtronic Heart ValvesSanta Ana, CA 92705

Approval to use two new autoclaves.

P980050/S0847/23/13Real-Time

Transvene Lead

Medtronic, Inc. Mounds View, MN 55112

Approval for an access in the accumulator shelf activity of the Tyvek lid component, which includes the adhering coating, acclimated in the Medtronic Cardiac Rhythm Disease Administration articles from 18 months to 48 months.

P990001/S1127/23/13Real-Time

Vitatron C20 SR, Vitatron C60 DR, Vitatron T20 SR, Vitatron T60 DR IPGs

Medtronic, Inc. Mounds View, MN 55112

Approval for an access in the accumulator shelf activity of the Tyvek lid component, which includes the adhering coating, acclimated in the Medtronic Cardiac Rhythm Disease Administration articles from 18 months to 48 months.

P990025/S0357/22/13135-Day

NaviStar, NaviStar RMT, EZ Steer Nay Catheters and BW Cables

Biosense Webster, Inc. Diamond Bar, CA 91765

Approval for the alteration of the Grinding Action from Irwindale, California accomplishment ability to Juarez, Mexico accomplishment facility.

P990046/S0347/30/13Special

Open Pivot Heart Valve and Open Pivot Aortic Valved Graft

Medtronic, Inc. Minneapolis, MN 55432

Approval for alteration the account of abeyant adverse contest in the Instructions for Use.

P990064/S0497/31/13135-Day

Mosaic® Porcine Bioprosthesis

Medtronic Heart ValvesSanta Ana, CA 92705

Approval to use two new autoclaves.

P990071/S0237/17/13Real-Time

SMARTA-BLATE™ Arrangement and SMARTA-BLATE™ Irrigation Pump kit

Biosense Webster, Inc. Diamond Bar, CA 91765

Approval for a accessory software amend for SMARTA-BLATE™ Irrigation Pump from Adaptation 1.2 to 1.3.

P990081/S0177/23/13Real-Time

PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody

Ventana Medical Systems, Inc. Tucson, AZ 85755

Approval for modifications in architecture to anticipate decay arrangement overflow or added leaks from causing shorting altitude with the BenchMark ULTRA’s centralized circuits.

P990081/S0197/25/13Real-Time

PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody

Ventana Medical Systems, Inc. Tucson, AZ 85755

Approval for accessory modifications to the architecture of the dispenser inwhich the PMA reagents in the accessories are stored and or used, including a change in the materialsthe assorted dispenser genitalia are fabricated from.

P000039/S0497/26/13135-Day

AMPLATZER™ Septal Occluder and AMPLATZER™ Multi-Fenestrated Septal Occluder – “Cribiform”

AGA Medical Corporation Plymouth, MN 55442

Approval for an alternating antecedent of accepted bioburden and sterility testing, as able-bodied as changes to the bioburden testing protocol.

P000040/S0287/9/13Real-Time

Genesys HTA System

Boston Scientific Corporation Marlborough, MA 01752

Approval for an activity directed adjustment action for the Genesys HTA clarify accumulation components.

P000040/S0307/19/13Real-Time

Genesys HTA System

Boston Scientific Corporation Marlborough, MA 01752

Approval for a change to the gold array blueprint of the cassette acquaintance pins from “flash gold” to ≥ 15 μ-inches and a modification to the agent tray so that the acquaintance pins do not acquaintance its lid.

P010014/S0447/30/13Special

[caption id="" align="aligncenter" width="400px"]Authentic Chinese Food | Arizona | Chou's Kitchen | chinese food near me 85281
[/caption]

Oxford® Partial Knee System

Biomet Accomplishment Corporation Warsaw, IN 46581

Approval for changes to the surgical address manual.

P010015/S2017/15/13Real-Time

Attain, Consulta, InSync, Syncra Cardiac Resynchronization Therapy- Pacemaker (CRT-Ps)

Medtronic, Inc. Mounds View, MN 55112

Approval for Cellular Connectivity for Remote Monitoring with Model 2020A CardioSight Reader and Models 2020B, 2020C Medtronic CareLink Express Monitors.

P010015/S2027/23/13Real-Time

Attain, Consulta, InSync, Syncra Cardiac Resynchronization Therapy- Pacemaker (CRT-Ps)

Medtronic, Inc. Mounds View, MN 55112

Approval for an access in the accumulator shelf activity of the Tyvek lid component, which includes the adhering coating, acclimated in the Medtronic Cardiac Rhythm Disease Administration articles from 18 months to 48 months.

P010030/S0427/22/13180-Day

LifeVest Wearable Defibrillator

ZOLL LifeCor Corporation Pittsburgh, PA 15238

Approval for software enhancements to the WCD 4000 LifeVest® Wearable Defibrillator and the consecutive affectation of that advice on the defended LifeVest.

P010031/S3767/15/13Real-Time

Concerto, Concerto CRT-D, Concerto II CRT-D, Consulta CRT-D, InSync II Marquis, InSync II Protect, InSync III Marquis, InSync Marquis, InSync Maximo, InSync Sentry, Consulta, Maximo II CRT-D, Protecta CRT-D, Protecta XT CRT-D, Brava CRT-D, Viva S CRT-D, Viva XT CRT-D

Medtronic, Inc. Mounds View, MN 55112

Approval for Cellular Connectivity for Remote Monitoring with Model 2020A CardioSight Reader and Models 2020B, 2020C Medtronic CareLink Express Monitors.

P010031/S3777/23/13Real-Time

Concerto, Concerto CRT-D, Concerto II CRT-D, Consulta CRT-D, InSync II Marquis, InSync II Protect, InSync III Marquis, InSync Marquis, InSync Maximo, InSync Sentry, Consulta, Maximo II CRT-D, Protecta CRT-D, Protecta XT CRT-D, Brava CRT-D, Viva S CRT-D, Viva XT CRT-D

Medtronic, Inc. Mounds View, MN 55112

Approval for an access in the accumulator shelf activity of the Tyvek lid component, which includes the adhering coating, acclimated in the Medtronic Cardiac Rhythm Disease Administration articles from 18 months to 48 months.

P010047/S0257/15/13180-Day

NeoMend ProGel Pleural Air Aperture Sealant

NeoMend, IncorporatedIrvine, CA 92618

Approval for a change in the aircraft temperature ambit to 1 °C to 30°C to acquiesce for abrupt accessible extremes in temperature during shipment. The Agency addendum that the "KeepRefrigerated" Label, C-00473, will to be added to the aircraft container.

P010047/S0267/25/13180-Day

NeoMend ProGel Pleural Air Aperture Sealant

NeoMend, IncorporatedIrvine, CA 92618

Approval for a change in the aircraft temperature ambit to 1ºC to 30°C to allowfor abrupt accessible extremes in temperature during shipment. The Agency addendum that the "KeepRefrigerated" Label, C-00473, will be added to the aircraft container.

P010068/S0327/22/13135-Day

Celsius DS, NaviStar DS, NaviStar RMT DS, EZ Steer Nav DS Catheters

Biosense Webster, Inc. Diamond Bar, CA 91765

Approval for the alteration of the Grinding Action from Irwindale, California accomplishment ability to Juarez, Mexico accomplishment facility.

P020024/S0397/26/13135-Day

AMPLATZER™ Duct Occluder

AGA Medical Corporation Plymouth, MN 55442

Approval for an alternating antecedent of accepted bioburden and sterility testing, as able-bodied as changes to the bioburden testing protocol.

P020055/S0087/25/13Real-Time

PATHWAY Anti-c-KIT (9.7) Rabbit Monoclonal Primary Antibody

Ventana Medical Systems, Inc. Tucson, AZ 85755

Approval for accessory modifications to the architecture of the dispenser inwhich the PMA reagents in the accessories are stored and or used, including a change in the materialsthe assorted dispenser genitalia are fabricated from.

P030005/S0997/25/13Real-Time

Invive, Intua ancestors of Cardiac Resynchronization Therapy Pacemakers (CRT-P), Application Software v1.09

Boston Scientific Corporation St. Paul, MN 55112

Approval for Model 2869 ZOOMVIEW Programmer Software Appliance v1.09 and Ingenio Firmware adaptation D_v1.02 with Patch v1.01 for the devices.

P030031/S0507/22/13135-Day

Celsius ThermoCool, Celsius RMT ThermoCool Catheters

Biosense Webster, Inc. Diamond Bar, CA 91765

Approval for the alteration of the Grinding Action from Irwindale, California accomplishment ability to Juarez, Mexico accomplishment facility.

P030036/S0587/23/13Real-Time

SelectSecure Lead

Medtronic, Inc. Mounds View, MN 55112

Approval for an access in the accumulator shelf activity of the Tyvek lid component, which includes the adhering coating, acclimated in the Medtronic Cardiac Rhythm Disease Administration articles from 18 months to 48 months.

P040020/S0457/23/13180-Day

AcrySof ReSTOR Apodized Diffractive IOLs

Alcon Research, Ltd.Fort Worth, TX 76134

Approval for a accomplishment armpit amid at Alcon Research, Ltd., in Lesage, West Virginia.

P040036/S0337/22/13135-Day

NaviStar ThermoCool, Navistar RMT Thermocool, EZ Steer ThermoCool Catheters

Biosense Webster, Inc. Diamond Bar, CA 91765

Approval for the alteration of the Grinding Action from Irwindale, California accomplishment ability to Juarez, Mexico accomplishment facility.

P040040/S0237/26/13135-Day

AMPLATZER™ Muscular VSD Occluder

AGA Medical Corporation Plymouth, MN 55442

Approval for an alternating antecedent of accepted bioburden and sterility testing, as able-bodied as changes to the bioburden testing protocol.

P040044/S0457/22/13180-Day

Mynx Vascular Closure Device

AccessClosure, Inc.Santa Clara, California 95054

Approval for a accomplishment armpit amid in Santa Clara, California.

P050006/S0357/17/13Special

Gore Helex Septal Occluder

W.L. Gore & AssociatesFlagstaff, AZ 86001

Approval to amend the absolute Gore Helex Septal Occluder Instructions forUse.

P050023/S0667/30/13Real-Time

Lumax Ancestors of ICD Accessories and CRT-D Devices

Biotronik, Inc. Lake Oswego, OR 97035

Approval for an alternating separator actual acclimated in the Litronik batteries for the devices.

P050023/S0677/30/13Real-Time

Ilesto 7 VR-T, Iforia 7 VR-T, Ilesto 5 VR-T, Iforia 5 VR-T, Lumax 700 VR-T, Lumax 600VR-T, Lumax 740 VR-T, Lumax 640 VR-T, Ilesto 7 VR-T DX, Iforia 7 VR-T DX, Ilesto 5VR-T DX, Iforia 5 VR-T DX, Lumax 740 VR-T DX, Lumax 640 VR-T DX, Ilesto 7 DRT,Iforia 7 DR-T, Ilesto 5 DR-T, Iforia 5 DR-T, Lumax 700 DR-T, Lumax 600 DR-T, Lumax 740 DR-T, Lumax 640 DR-T, Ilesto 7 HF-T, Iforia 7 HF-T, Ilesto 5 HF-T, Iforia 5 HF-T, Lumax 700 HF-T, Lumax 600 HF-T, Lumax 740 HF-T, Lumax 640 HF-T

Biotronik, Inc.Lake Oswego, OR 97035

Approval for the accessory labeling modifications/corrections, whichincludes an amend of the Indication for Use Statements (IFU) to accommodate the bazaar approveddevices with the aforementioned IFU, and added accessory corrections to the labeling.

P060022/S0167/1/13Real-Time

Akreos AO60 Intraocular Lens (IOL)

Bausch & Lomb Incorporated Aliso Viejo, CA 92656

Approval for a labeling change to accommodate the accession of a new intraocular lens (IOL) inserter, INJ100, in the Directions for Use.

P060039/S0477/23/13Real-Time

Attain StarFix Lead

Medtronic, Inc. Mounds View, MN 55112

Approval for an access in the accumulator shelf activity of the Tyvek lid component, which includes the adhering coating, acclimated in the Medtronic Cardiac Rhythm Disease Administration articles from 18 months to 48 months.

P070008/S0447/30/13Real-Time

Entovis HF(-T), Evia HF(-T) Ancestors of CRT-P Devices

Biotronik, Inc. Lake Oswego, OR 97035

[caption id="" align="aligncenter" width="400px"]Miu's Cuisine, Tempe - Restaurant Reviews, Phone Number | chinese food near me 85281
[/caption]

Approval for an alternating separator actual acclimated in the Litronik batteries for the devices.

P070026/S0087/17/13Real-Time

DePuy Ceramax Bowl absolute Hip System

Depuy, Inc. Warsaw, IN 46581

Approval for the accession of Summit Porocoat Stems as a accordant basic to the absolute 28mm bowl head.

P070026/S0147/2/13180-Day

CERAMAX® Bowl Absolute Hip System

Depuy, Inc. Warsaw, IN 46581

Approval of the post-approval abstraction protocol.

P080004/S0117/10/13180-Day

iSert® Preloaded Posterior Chamber Intraocular Lens

Hoya Surgical Optics Chico Hills, CA 91709

Approval for the iSert® Model 251 Preloaded Posterior Chamber Intraocular Lens (IOL) and iSert® Model 250 Preloaded Posterior Chamber IOL.

P080006/S0547/23/13Real-Time

Attain Ability Lead

Medtronic, Inc. Mounds View, MN 55112

Approval for an access in the accumulator shelf activity of the Tyvek lid component, which includes the adhering coating, acclimated in the Medtronic Cardiac Rhythm Disease Administration articles from 18 months to 48 months.

P080011/S0247/16/13180-Day

CooperVision comfilcon A Soft (Hydrophilic) Extended Wear Acquaintance Lenses

CooperVision™, Incorporated Pleasanton, CA 94588

Approval to add the new cast name Biofinity XR.

P080012/S0167/2/13Real-Time

Prometra Programmable Implantable Pump

Flowonix Medical, Incorporated Mount Olive, NJ 07828

Approval for the accession of an alternating sub-tier supplier and actual change for the molded silicone cannula ache abatement and clarify seal, which are both apparatus of the implantable pump.

P080032/S0127/3/13180-Day

Alair Bronchial Thermoplasty System

Boston Scientific CorporationMarlborough, MA 01752

Approval for 1) the accomplishment alteration of the Alair Catheter from the accepted ability in Sunnyvale, California, to the Boston Scientific ability in Cork, Ireland; and 2) thequalification of Synergy Health Ireland Ltd, amid in Tullamore, Ireland, as a sterilization sitefor the Alair Catheter, and accessory architecture changes to the Alair Catheter.

P090013/S0987/15/13Real-Time

 Revo MRI

Medtronic, Inc.  Mounds View, MN 55112

Approval for Cellular Connectivity for Remote Monitoring with Model 2020A CardioSight Reader and Models 2020B, 2020C Medtronic CareLink Express Monitors.

P090013/S0997/23/13Real-Time

CapSureFix MRI Lead, Revo MRI IPG

Medtronic, Inc. Mounds View, MN 55112

Approval for an access in the accumulator shelf activity of the Tyvek lid component, which includes the adhering coating, acclimated in the Medtronic Cardiac Rhythm Disease Administration articles from 18 months to 48 months.

P090022/S0177/25/13Real-Time

Softec HD™, Softec HD™ PS, Softec HDO™ and Softec I™ Posterior Chamber Intraocular Lenses (IOLs)

Lenstec, Inc. St. Petersburg, FL 33716

Approval for a altered commitment system, the accessory which holds the intraocular lens (IOL) in abode aural its acrid abounding vial.

P100010/S0307/26/13Real-Time

Arctic Front Cardiac CryoAblation Catheters,  Arctic Front Advance Cardiac CryoAblation Catheters

Medtronic CryoCath LP Marie Kirkland, Quebec, CanadaH9H 5H3

Approval for the abatement of the alien aperture apprehension wire and associated inductor.

P100022/S0067/19/13Special

Zilver PTX Drug-Eluting Peripheral Stent (6 – 8 mm diameter; 20 – 120 mm length)

Cook, Inc. Bloomington, IN 47402

Approval for modifications to the Instructions For Use (IFU) to advance accuracy by accouterment recommendations for adapted guidewire alternative and added instructions for back attrition is encountered during catheter use.

P100027/S0077/22/13Real-Time

INFORM HER2 Dual ISH DNA Probe

Ventana Medical Systems, Inc. Tucson, AZ 85755

Approval for modifications in architecture to anticipate decay arrangement overflow or added leaks from causing shorting altitude with the BenchMark ULTRA’s centralized circuits.

P100027/S0097/25/13Real-Time

INFORM HER2 Dual ISH DNA Probe

Ventana Medical Systems, Inc. Tucson, AZ 85755

Approval for accessory modifications to the architecture of the dispenser inwhich the PMA reagents in the accessories are stored and or used, including a change in the materialsthe assorted dispenser genitalia are fabricated from.

P100042/S0017/15/13180-Day

APTIMA® HPV Assay

Gen-Probe Incorporated San Diego, CA 92121

Approval for the accession of the PANTHER Arrangement to the APTIMA® HPV Assay. The device, as modified, will be marketed beneath the barter name APTIMA® HPV Assay. The APTIMA HPV Appraisal is an in vitro nucleic acerbic addition analysis for the qualitative apprehension of E6/E7 viral agent RNA (mRNA) from 14 high-risk types of animal papillomavirus (HPV) in cervical specimens. The high-risk HPV types detected by the appraisal include: 16, 18, 31, 33, 35, 39, 45, 51, 52,56, 58, 59, 66, and 68. The APTIMA HPV Appraisal does not discriminate amid the 14 high-risk types. Cervical specimens calm in ThinPrep Pap Analysis vials absolute PresesrvCyt Solution and calm with broom-type or cytobrush/spatula accumulating devices* may be activated with the APTIMA HPV Assay. The appraisal is acclimated with the TIGRIS DTS Arrangement or the PANTHER System. The use of the analysis is indicated: 1) To awning women 21 years and earlier with aberant squamous beef of undetermined acceptation (ASC-US) cervical analysis after-effects to actuate the charge for barometer to colposcopy. The after-effects of this analysis are not advised to anticipate women from proceeding to colposcopy; and 2) In women 30 years and older, the APTIMA HPV Appraisal can be acclimated with cervical analysis to adjunctively awning to appraise the attendance or absence of high-risk HPV types. This information, calm with the physician’s appraisal of analysis history, added accident factors, and able guidelines, may be acclimated to adviser accommodating management. *Broom-type accessory (e.g., Wallach Pipette) or endocervical brush/spatula.

P100044/S0087/17/13180-Day

Propel™ Mini Sinus Implant

Intersect ENT Menlo Park, CA 94025

Revise the adherence agreement to reflect the biologic absolution accepting belief of ± 12% of the ambition amount acclimated for artefact release.

P100047/S0227/3/13Special

HeartWare Ventricular Assist System

HeartWare, Inc. Miami Lakes, FL 33014

Approval for updates to the Instructions for Use and Accommodating Chiral of the accessory to accommodate warnings and advice accompanying to electrostatic acquittal acknowledgment and exchanging ability sources.

P110010/S0507/15/13135-Day

PROMUS Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent Arrangement (Monorail® and Over-The-Wire)

Boston Scientific Corporation Maple Grove, MN 55311

Approval for an advancement to an analysis arrangement camera and software.

P110013/S0177/2/13180-Day

Resolute Integrity Zotarolimus-Eluting Coronary Stent System

Medtronic Vascular Santa Rosa, CA 95403

Approval for an adapted Annual Adherence agreement to bracket the added 34 mm and 38 mm breadth stent sizes.

P110016/S0037/30/13180-Day

Cool Path Duo Ablation Catheter, MediGuide Enabled and Safire Duo Ablation Catheter, MediGuide Enabled

St. Jude Medical Minnetonka, MN 55345

Approval for  adding a MediGuide Technology acquiescent sensor into the tip of the accessory for the purposes of acceptable aeronautics and  changing the Cool Path Duo Uni-Directional (Uni-D) handle to a Cool Path Duo Bi-Directional (Bi-D) handle. The devices, as modified, will be marketed beneath the barter names Cool Path™ Duo Ablation Catheter, MediGuide Enabled™ and Safire™ Duo Ablation Catheter, MediGuide Enabled™ and are adumbrated for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation, and ablation) for the analysis of archetypal atrial flutter. The catheters are advised for use with a accordant alien pump and the IBI-1500T9-CP RF Generator at a best of 50 watts. MediGuide Enabled™ Ablation Catheters are acclimated with the MediGuide™ Technology to accredit real-time tip accession and navigation. The MediGuide™ Technology is adumbrated for use as an accessory to fluoroscopy.

P110019/S0437/15/13Real-Time

XIENCE Xpedition™ Everoliums Eluting Coronary Stent System, XIENCE Xpedition™ LL Everolimus Eluting Coronary Stent, System, XIENCE Xpedition™ SV Everolimus Eluting Coronary Stent System

Abbott Vascular Temecula, CA 92591

Approval to amend the labeling for the Xience Xpedition, Xience Xpedition SV, and Xience Xpedition LL Everolimus Eluting Coronary Stent Rapid Exchange (RX) Arrangement to reflect a 24-month shelf life.

P110019/S0457/26/13180-Day

XIENCE PRIME Stent Systems

Abbott Vascular Temecula, CA 92591

Approval of the post-approval abstraction protocol.

P110021/S0047/2/13180-Day

Edwards SAPIENTM Transcatheter Heart Valve with RetroFlex 3 Commitment Arrangement Edwards SAPIENTMTranscatheter Heart Valve with Ascendra Commitment Arrangement and accessories (RetroFlexTm Balloon Catheter, AscendraM Balloon Aortic Valvuloplasty Catheter, Ascendram Administrator Sheath Set;and Crimper

Edwards Lifesciences, LLCIrvine, CA 92614

Approval for architecture modifications to the Ascendra Balloon Catheter, Models9100BCL23 (23mm) and 9100BCL26 (26mm), and the Ascendra Administrator Sheath Set, Model91001S. The device, as modified, will bemarketed beneath the barter name Ascendra 3 Commitment System, Models 9120AS23 (23mm) and 9120AS26 (26mm) and Ascendra 3 Administrator Sheath Set, Model 9120IS (26F) and is indicatedfor the transapical commitment of the Edwards SAPIEN Transcatheter Heart Valve (delivery system)and for the accession and abatement of accessories acclimated with the Edwards SAPIEN TranscatheterHeart Valve (introducer sheath set).



Five Doubts You Should Clarify About Chinese Food Near Me 85281. | chinese food near me 85281 - chinese food near me 85281
| Welcome to help our website, within this occasion We'll show you in relation to keyword. Now, this is actually the initial picture:

[caption id="" align="aligncenter" width="400px"]Spice Spirit | Order Online | Mesa, AZ 85201 | ChineseSpice Spirit | Order Online | Mesa, AZ 85201 | Chinese | chinese food near me 85281
[/caption]

How about graphic previously mentioned? will be in which incredible???. if you think therefore, I'l l teach you many picture all over again underneath:

So, if you want to receive all of these fantastic pics about (Five Doubts You Should Clarify About Chinese Food Near Me 85281. | chinese food near me 85281), click save icon to save these images to your computer. These are prepared for transfer, if you like and want to get it, just click save badge on the web page, and it will be instantly downloaded to your computer.} Finally if you desire to get unique and the latest image related to (Five Doubts You Should Clarify About Chinese Food Near Me 85281. | chinese food near me 85281), please follow us on google plus or book mark this page, we attempt our best to offer you regular up-date with fresh and new shots. Hope you love keeping here. For many upgrades and recent news about (Five Doubts You Should Clarify About Chinese Food Near Me 85281. | chinese food near me 85281) pics, please kindly follow us on tweets, path, Instagram and google plus, or you mark this page on book mark section, We attempt to offer you update regularly with all new and fresh pictures, enjoy your searching, and find the best for you.

Thanks for visiting our website, articleabove (Five Doubts You Should Clarify About Chinese Food Near Me 85281. | chinese food near me 85281) published .  Today we're delighted to declare that we have discovered an incrediblyinteresting contentto be discussed, namely (Five Doubts You Should Clarify About Chinese Food Near Me 85281. | chinese food near me 85281) Many individuals trying to find information about(Five Doubts You Should Clarify About Chinese Food Near Me 85281. | chinese food near me 85281) and certainly one of them is you, is not it?[caption id="" align="aligncenter" width="400px"]Mijana Restaurant, Tempe - Menu, Prices Mijana Restaurant, Tempe - Menu, Prices | chinese food near me 85281
[/caption]
[caption id="" align="aligncenter" width="400px"]Villa Peru, Tempe - 1745 East River Road suite 165 - Menu, Prices ...Villa Peru, Tempe - 1745 East River Road suite 165 - Menu, Prices ... | chinese food near me 85281
[/caption]
[caption id="" align="aligncenter" width="400px"]Loco Patron. Really good food! 'Nuf said. 222 S Mill Ave, Tempe ... | chinese food near me 85281
[/caption]
[caption id="" align="aligncenter" width="400px"]Gluttons - CLOSED - 33 Photos Gluttons - CLOSED - 33 Photos | chinese food near me 85281
[/caption]
[caption id="" align="aligncenter" width="400px"]Khai Hoan RestaurantKhai Hoan Restaurant | chinese food near me 85281
[/caption]