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Home » Medtech approvals: FDA releases February 2014 PMAs

Medtech approvals: FDA releases February 2014 PMAs

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Summary of PMA Originals & Supplements Approved 
Originals: 1 
Supplements: 60

Summary of PMA Originals Under Review 
Total Under Review: 51 
Total Active: 23 
Total On Hold: 28

Summary of PMA Supplements Under Review 
Total Under Review: 586 
Total Active: 418   
Total On Hold: 168

Summary of All PMA Submissions Received
Originals: 1 
Supplements: 69

Summary of PMA Supplement PMA Approval/Denial Decision Times 
Number of Approvals: 60 
Number of Denials: 0 
Average Days Fr Receipt to Decision (Total Time): 137.8  
FDA Time: 107.3 Days MFR Time: 30.4 Days

PMA Original Approvals

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P090031
2/25/14		 MONOVISC™ Injectable Intra-articular Device Anika Therapeutics, Incorporated
Bedford, MA 01730		 Approval for the MONOVISC™ Injectable Intra-articular Device. This device is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and to simple analgesics (e.g., acetaminophen).

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P830061/S086
2/18/14
180-Day		 CapSure Sense Family of Leads Medtronic, Inc.
Mounds View, MN 55112		 Approval for removal of the Dexamethasone Sodium Phosphate (DSP) coating from the lead tip and the Manufacturing Site Change for the Monolithic Controlled Release Device (MCRD) for the CapSure Sense Family of Leads.
P850079/S063
2/21/14
135-Day		 Coopervision Methafilcon A Soft Extended Wear Contact Lenses Coopervision, Inc.
Pleasanton, CA 94588		 Approval for the manufacture of the device on another manufacturing line and further that orders with low volume requirements will be lathed on the front surface, rather than fully molded as large volume orders are.
P860004/S202
2/25/14
Special		 Medtronic SynchroMed Infusion System Medtronic Neuromodulation
Minneapolis, MN 55432		 Approval for device refill kit Model 8551to reorder the warnings and precautions according to medical importance, to remove information found in the previously approved Instructions For Use that is not applicable to Model 8551, and to align verbiage with the updated Model 856X Refill Kit Instructions For Use.
P890003/S285
2/14/14
180-Day		 MyCareLink Monitor Medtronic, Inc.
Mounds View, MN 55112		 Approval for updates to the Medtronic MyCareLink Patient Monitor Model 24950, Reader Model 24955, and accessories, Model 2491 Device Data Management Application (DDMA) and Application Software SW026 to support Medtronic’s Reveal LINQ Insertable Cardiac Monitors (ICM).
P890003/S295
2/27/14
180-Day		 DDMA Medtronic CRDM
Mounds View, MN 55112		 Approval for post sterilization test firmware, programmer application software and labeling for the  devices.
P890003/S299
2/27/14
Real-Time		 Consulta, Syncra Medtronic, Inc.
Mounds View, MN 55112		 Approval for software changes to the MyCareLink Patient Monitor M2.5 Model 24950 with Model 24955 RF Head which supports the devices and Medtronic’s Reveal Insertable Cardiac Monitors Models 9529, 9528 and LNQ11. The MyCareLink Patient Monitor is indicated for transmission of implantable device data to the CareLink Network for the clinic to review.
P950009/S017
2/26/14
Real-Time		 BD FocalPoint™ Slide Profiler BD Diagnostics
Durham, NC 
27703		 Approval for replacement of the current Scan Controller Board (SCB) utilized in the BD FocalPoint™ Slide Profiler with digital image system configuration.
P950022/S085
2/21/14
180-Day		 Optisure High Voltage Lead Family St. Jude Medical, Inc.
Sylmar, CA 
91342		 Approval for the Optisure High Voltage Lead Family.
P970021/S039
2/24/14
180-Day		 Gynecare Thermachoice Uterine Balloon Therapy System Ethicon, Inc.
Somerville, NJ 08876		 Approval for a manufacturing site located at Plexus Corporation in Buffalo Grove, Illinois.
P970058/S026
2/10/14
180-Day		 ImageChecker CAD 10.0 Hologic, Inc.
Santa Clara, CA 95054		 Approval of ImageChecker CAD 10.0 for use with C-View images synthesized by the Hologic Selenia Dimensions system.
P980016/S436
2/14/14
180-Day		 EnTrust, Intrinsic, Marquis, Maximo, Evera, Protecta, Secura, Virtuoso Medtronic, Inc.
Mounds View, MN 55112		 Approval for updates to the Medtronic MyCareLink Patient Monitor Model 24950, Reader Model 24955, and accessories, Model 2491 Device Data Management Application (DDMA) and Application Software SW026 to support Medtronic’s Reveal LINQ Insertable Cardiac Monitors (ICM).
P980016/S451
2/27/14
180-Day		 Evera ICDs Evera, Viva/Brava/Evera Programmer Application Software Medtronic CRDM
Mounds View, MN 55112		 Approval for post sterilization test firmware, programmer application software and labeling for the  devices.
P980016/S454
2/27/14
Real-Time		 EnTrust, Intrinsic, Marquis, Maximo, Evera, Protecta, Secura, Virtuoso Medtronic, Inc.
Mounds View, MN 55112		 Approval for software changes to the MyCareLink Patient Monitor M2.5 Model 24950 with Model 24955 RF Head which supports the  devices and Medtronic’s Reveal Insertable Cardiac Monitors Models 9529, 9528 and LNQ11. The MyCareLink Patient Monitor is indicated for transmission of implantable device data to the CareLink Network for the clinic to review.
P980035/S343
2/14/14
180-Day		 Adapta, Versa, Sensia, Advisa, EnPulse, EnRhythm, Kappa Medtronic, Inc.
Mounds View, MN 55112		 Approval for updates to the Medtronic MyCareLink Patient Monitor Model 24950, Reader Model 24955, and accessories, Model 2491 Device Data Management Application (DDMA) and Application Software SW026 to support Medtronic’s Reveal LINQ Insertable Cardiac Monitors (ICM).
P980035/S360
2//27/14
Real-Time		 Adapta, Versa, Sensia, Advisa, EnPulse, EnRhythm, Kappa Medtronic, Inc.
Mounds View, MN 55112		 Approval for software changes to the MyCareLink Patient Monitor M2.5 Model 24950 with Model 24955 RF Head which supports the devices and Medtronic’s Reveal Insertable Cardiac Monitors Models 9529, 9528 and LNQ11. The MyCareLink Patient Monitor is indicated for transmission of implantable device data to the CareLink Network for the clinic to review.
P990064/S053
2/5/14
Special		 MOSAIC® Porcine Bioprosthesis Medtronic, Inc.
Santa Ana, CA 92705		 Approval for the inclusion of an indexed Effective Orifice Area (iEOA) sizing chart in the IFU and an update to the sizers to align with the updated iEOA sizing chart.
P010015/S215
2/14/14
180-Day		 Consulta, Syncra Medtronic, Inc.
Mounds View, MN 55112		 Approval for updates to the Medtronic MyCareLink Patient Monitor Model 24950, Reader Model 24955, and accessories, Model 2491 Device Data Management Application (DDMA) and Application Software SW026 to support Medtronic’s Reveal LINQ Insertable Cardiac Monitors (ICM).
P010015/S217
2/27/14
180-Day		 InSync and InSync III Biventricular Pacing Systems Medtronic, Inc.
Mounds View, MN 55432		 Approval for a labeling update to include the results from the Post-Approval Study, specifically the Medtronic InSync Registry Post Approval Study.
P010015/S229
2/27/14
Real-Time		 MyCareLink Patient Monitor M2.5 with RF Head Medtronic, Inc.
Mounds View, MN 55112		 Approval for software changes to the MyCareLink Patient Monitor M2.5 Model 24950 with Model 24955 RF Head which supports the devices and Medtronic’s Reveal Insertable Cardiac Monitors Models 9529, 9528 and LNQ11. The MyCareLink Patient Monitor is indicated for transmission of implantable device data to the CareLink Network for the clinic to review.
P010031/S397
2/14/14
180-Day		 InSync, Brava, Concerto, Consulta, Maximo, Protecta, Viva Medtronic, Inc.
Mounds View, MN 55112		 Approval for updates to the Medtronic MyCareLink Patient Monitor Model 24950, Reader Model 24955, and accessories, Model 2491 Device Data Management Application (DDMA) and Application Software SW026 to support Medtronic’s Reveal LINQ Insertable Cardiac Monitors (ICM).
P010031/S413
2/27/14
180-Day		 Brava/Viva CRT-Ds Brava.Viva /Evera Programmer Application Software Medtronic CRDM
Mounds View, MN 55112		 Approval for post sterilization test firmware, programmer application software and labeling for the  devices.
P010031/S416
2/27/14
Real-Time		 InSync, Brava, Concerto, Consulta, Maximo, Protecta, Viva Medtronic, Inc.
Mounds View, MN 55112		 Approval for software changes to the MyCareLink Patient Monitor M2.5 Model 24950 with Model 24955 RF Head which supports the devices and Medtronic’s Reveal Insertable Cardiac Monitors Models 9529, 9528 and LNQ11. The MyCareLink Patient Monitor is indicated for transmission of implantable device data to the CareLink Network for the clinic to review.
P030017/S181
2/16/14
180-Day		 Precision Spectra Spinal Cord Stimulation System Boston Scientific
Valencia, CA 
91355		 Approval for head-only magnetic resonance conditional (i.e., MR Conditional) labeling for the Precision Spectra Spinal Cord Stimulation (SCS) System.
P030031/S053
2/11/14
180-Day		 ThermoCool Catheters For the Treatment of Type I Atrial Flutter and Atrial Fibrillation Biosense Webster, Inc.
Diamond Bar, CA 91765		 Approval for the addition of force sensing technology to the catheter tip. The device, as modified, will be marketed under the trade name ThermoCool SmartTouch catheter and is indicated for: The Biosense Webster ThermoCool SmartTouch Navigation Catheter and related accessory devices are indicated for catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used with a compatible RF generator, for the treatment of: 1) Type I atrial flutter in patients age 18 or older; 2) Recurrent drug/device refractory sustained monomorphic ventricular tachycardia (VT) due to prior myocardial infarction (MI) in adults; and 3) Drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems. The ThermoCool SmartTouch Navigation Catheter provides a real-time measurement of contact force between the catheter tip and heart wall, as well as location information when used with CARTO 3 Navigation System.
P030053/S013
2/24/14
Real-Time		 Mentor MemoryGel® Silicone Gel-Filled Breast Implants Mentor Worldwide LLC
Santa Barbara, CA 93111		 Approval for the addition of seven styles including four Smooth Round Ultra High Profile devices: 350-5650BC, 350-57000BC, 350-5750BC, and 350-5800BC; and three Siltex Round Ultra High Profile devices: 354-5590, 354-5650, and 354-5700.
P040002/S045
2/6/14
180-Day		 AFX Endovascular AAA System (AFX System) Endologix, Inc.
Irvine, CA 
92618		 Approval for the addition of a contract sterilizer located at STERIS-Isomedix Services,  in Temecula, California.
P040036/S037
2/11/14
180-Day		 ThermoCool Catheters For the Treatment of Ventricular Tachycardia Biosense Webster, Inc.
Diamond Bar, CA 91765		 Approval for the addition of force sensing technology to the catheter tip. The device, as modified, will be marketed under the trade name ThermoCool SmartTouch catheter and is indicated for: The Biosense Webster ThermoCool SmartTouch Navigation Catheter and related accessory devices are indicated for catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used with a compatible RF generator, for the treatment of: 1) Type I atrial flutter in patients age 18 or older; 2) Recurrent drug/device refractory sustained monomorphic ventricular tachycardia (VT) due to prior myocardial infarction (MI) in adults; and 3) Drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems. The ThermoCool SmartTouch Navigation Catheter provides a real-time measurement of contact force between the catheter tip and heart wall, as well as location information when used with CARTO 3 Navigation System.
P050037/S046
2/27/14
135-Day		 Radiesse Dermal Filler Merz North America, Inc.
Franksville, WI 53126		 Approval for in-sourcing testing of a raw material component of the Radiesse product.
P050038/S019
2/27/14
Real-Time		 ARISTA™ AH Absorbable Hemostatic Particles Medafor Incorporated
Minneapolis, MN 55429		 Approval for a larger (18 gram) bellow container for the 5 gram ARISTA AH device and increases in the dimensions of the device packaging, specifically, the foil and Tyvek pouches and shelf and shipper boxes.
P050044/S026
2/11/14
Real-Time		 Vitagel™ Surgical Hemostat Stryker Orthobiologics
Malvern, PA
19355		 Approval for the following changes to the VitaPrep Plasma Separator component of Vitagel Surgical Hemostat: addition of hydrafoam and silicone O-ring inserts to the inside of the cap, increase in the length of the plunger stopper support, remolding of the cap, and update in the primary packaging.
P050052/S050
2/27/14
135-Day		 Radiesse Dermal Filler Merz North America, Inc.
Franksville, WI 53126		 Approval for in-sourcing testing of a raw material component of the Radiesse product.
P060037/S024
2/18/14
135-Day		 NexGen LPS Flex Mobile Bearing Knee Zimmer Orthopedics Manufacturing Limited
Shannon, Co. Clare
Ireland		 Approval for replacing the manual labeling verification process with an automated system.
P080012/S019
2/4/14
180-Day		 Prometra Programmable Implantable Pump Flowonix Medical, Incorporated
Mount Olive, NJ 07828		 Approval for the addition of a catheter revision kit for use with the subject system. The device, as modified, will be marketed under the trade name Prometra Programmable Implantable Pump System and is indicated for intrathecal infusion of Infumorph® (preservative-free morphine sulfate) or preservative-free sterile 0.9% saline solution (Sodium Chloride Injection, USP).
P080013/S008
2/6/14
180-Day		 DuraSeal Xact Sealant System Integra Lifesciences Corporation
Bedford, MA 
01801		 Approval of the post-approval study protocol.
P090013/S112
2/14/14
180-Day		 Revo MRI Medtronic, Inc.
Mounds View, MN 55112		 Approval for updates to the Medtronic MyCareLink Patient Monitor Model 24950, Reader Model 24955, and accessories, Model 2491 Device Data Management Application (DDMA) and Application Software SW026 to support Medtronic’s Reveal LINQ Insertable Cardiac Monitors (ICM).
P090013/S124
2/27/14
Real-Time		 Revo MRI Medtronic, Inc.
Mounds View, MN 55112		 Approval for software changes to the MyCareLink Patient Monitor M2.5 Model 24950 with Model 24955 RF Head which supports the devices and Medtronic’s Reveal Insertable Cardiac Monitors Models 9529, 9528 and LNQ11. The MyCareLink Patient Monitor is indicated for transmission of implantable device data to the CareLink Network for the clinic to review.
P090015/S001
2/11/14
180-Day		 BOND ORACLE HER2 IHC System Leica Biosystems
Tyne, UK
NE128EW		 Approval for the manufacturing changes to the BOND-MAX software, instrument styling and usability, the reagent and BOND-MAX instrument manufacturing processes, and associated labeling changes.
P100014/S011
2/26/14
180-Day		 Solesta Injectable Gel Salix Pharmaceuticals, Inc.
Raleigh, NC 
27615		 Approval of the post-approval study protocol.
P100025/S006
2/19/14
Special		 BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit) and Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA), Version 1.0 Otsuka Pharmaceutical Development and Commercialization, Incorporated
Rockville, MD 20850		 Approval for the changes to the releasing specification for 13C-urea to comply with the USP monograph changes.
P100026/S003
2/7/14
180-Day		 Neuropace RNS System Neuropace, Inc.
Mountain View, CA 
94043		 Approval of the post-approval study protocol.
P100026/S004
2/24/14
180-Day		 Neuropace RNS System Neuropace, Inc.
Mountain View, CA 
94043		 Approval of the post-approval study protocol.
P100026/S005
2/18/14
180-Day		 Neuropace RNS System Neuropace, Inc.
Mountain View, CA
94043		 Approval of the post-approval study protocol.
P100026/S006
2/14/14
180-Day		 Neuropace RNS System Neuropace, Inc.
Mountain View, CA
94043		 Approval of the post-approval study protocol.
P100041/S047
2/12/14
Special		 Crimper (accessory for crimping Edwards SAPIEN® Transcatheter Heart Valve) Edwards Lifesciences, LLC
Irvine, CA 
92614		 Approval for the addition of labeling to indicate the contents of dry natural rubber in the device packaging.
P100047/S026
2/14/14
180-Day		 HeartWare Ventricular Assist System Heartware, Inc.
Miami, FL 
33014		 Approval of the post-approval study protocol.
P100047/S033
2/13/14
Real-Time		 HeartWare Ventricular Assist System Heartware, Inc.
Miami, FL 
33014		 Approval for use of a new formulation of the thermoplastic vulcanizate (TPZ) material used in the manufacture of the Monitor Data Cable, Battery Pack Cable, DC Adaptor Input Cable, and Alarm Silence Adaptor components of the device.
P110006/S002
2/11/14
Real-Time		 Invenia ABUS Automated Breast Ultrasound System GE Healthcare
Wauwatosa, WI 53226		 Approval for change in the labeling materials (revised Scan Station User’s Manual, Workstation User’s Manual, and User Training Program, as well as new Patient Positioning Guide, Quick Reference Guide – Positioning, Product Datasheet, and Basic Service Manual).
P110010/S058
2/13/14
180-Day		 PROMUS Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail™ and Over-the-Wire) Boston Scientific Corporation
Maple Grove, MN 55311		 Approval for the addition of the active pharmaceutical ingredient, everolimus variant 2.
P110013/S007
2/5/14
180-Day		 Resolute Integrity Zotarolimus-Eluting Coronary Stent System Medtronic Vascular
Santa Rosa, CA 95403		 Approval to tighten the in-process post-dry drug weight specifications to +/-7% (93-107%), and to reduce the current manufacturing overage from 5% to 3%.
P110013/S024
2/5/14
135-Day		 Resolute Integrity Zotarolimus-Eluting Coronary Stent System Medtronic Vascular
Santa Rosa, CA 95403		 Approval for a modification to the Residual Solvents analytical test method used for the testing of the C10 and C19 polymers, which are a component of the stent coating.
P110019/S053
2/28/14
180-Day		 XIENCE PRIME, XIENCE PRIME Long Lesion, XIENCE Xpedition, XIENCE Xpedition Small Vessel and XIENCE Xpedition Long Lesion Everolimus Eluting Coronary Stent System Abbott Vascular
Santa Clara, CA 95054		 Approval for an update to the labeling to reflect the three year post approval study findings from the SPIRIT PRIME clinical trial.
P110021/S034
2/12/14
Special		 Crimper (accessory for crimping Edwards SAPIEN® Transcatheter Heart Valve) Edwards Lifesciences, LLC
Irvine, CA 
92614		 Approval for the addition of labeling to indicate the contents of dry natural rubber in the device packaging.
P120005/S002
2/3/14
Panel-Track		 Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System Dexcom Inc.
San Diego, CA 92121		 Approval for the Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System. This device is indicated for: The Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons ages 2 to 17 years with diabetes. The system is intended for single patient use and requires a prescription. The Dexcom G4 PLATINUM (Pediatric) System is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices. The Dexcom G4 PLATINUM (Pediatric) System aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions. Interpretation of the Dexcom G4 PLATINUM (Pediatric) System results should be based on the trends and patterns seen with several sequential readings over time.
P120005/S013
2/26/14
Real-Time		 Dexcom G4 PLATINUM Continuous Glucose Monitoring System Dexcom, Inc.
San Diego, CA 92121		 Approval for end of life component changes (speaker driver-codec, flash, MOSFET, SDRAM, Capacitor (CAP), and RF CHIP) in the receiver printed circuit board assembly, use of a higher capacity capacitor and improvement in the method of attachment of a USB Port connector in the G4 PLATINUM Continuous Glucose Monitoring System.

30-Day Notices (135 Day Supplement was not required)

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
N970003/S158
2/27/14		 FORMIO, VITALIO, ADVANTIO, INGENIO Pacemakers Boston Scientific Corporation
Saint Paul, MN 55112		 Add inspection criteria at the spot-welding step before spot-welding the feedthru wires to the connector blocks.
P830061/S106
2/4/14		 CapSure Lead Medtronic CRDM
Mounds View, MN 55112		 Alternate manufacturing facility of existing supplier, and utilization of Supplier Quality Management (SQM) as the incoming inspection control for thermoformed blister trays.
P830061/S107
2/27/14		 CAPSUREFIX MRI Lead Medtronic Inc.
Mounds View, MN 55112		 Reduction in frequency of environmental monitoring testing in specific manufacturing areas.
P850064/S026
2/19/14		 Life Pulse High Frequency Ventilator Patient Circuit Bunnell, Incorporated
Salt Lake City, UT 84115		 Addition of a new ultrasonic welder.
P850089/S106
2/27/14		 CAPSURE SP NOVUS, CAPSURE SP Z, CAPSURE Z NOVUS Leads Medtronic Inc.
Mounds View, MN 55112		 Reduction in frequency of environmental monitoring testing in specific manufacturing areas.
P890003/S302
2/27/2017		 CAPSURE Lead Medtronic Inc.
Mounds View, MN 55112		 Reduction in frequency of environmental monitoring testing in specific manufacturing areas.
P900056/S131
2/13/14		 Rotablator Rotational Angioplasty System Guidewire Boston Scientific Corporation
Maple Grove, MN 55311		 Equipment change to one of the ethylene oxide sterilization chambers.
P900060/S053
2/20/14		 Carbomedics Prosthetic Heart Valve (CPHV™) Sorin Group USA, Inc.
Arvada, CO 
80004		 Modified in-process inspection for detection of material deposits.
P900061/S127
2/27/14		 END CAP, SIZING SLEEVE, UPSIZING SLEEVE Medtronic Inc.
Mounds View, MN 55112		 Reduction in frequency of environmental monitoring testing in specific manufacturing areas.
P910007/S042
2/3/14		 Architect Total PSA Abbott Laboratories
Abbott Park Lake, IL 
60064		 Change to the quality control testing used on in-process materials.
P910023/S325
2/6/14		 Fortify, Fortify Assura, and Ellipse Implantable Cardioverter Defibrillators St. Jude Medical
Sylmar, CA 
91342		 Change in the hydrohone process.
P910023/S327
2/18/14		 Current DR; Current DR RF; Current Accel DR; Current+ DR; Current VR; Current VR RF; Current Accel VR; Current+ VR; Ellipse DR; Ellipse VR; Fortify DR; Fortify VR; Fortify Assura; Fortify Assura VR St. Jude Medical
Sylmar, CA 
91342		 XTS Anode Foil Etching Additive for manufacturing of the high voltage capacitors for the devices.
P920015/S129
2/27/14		 SPRINT QUATTRO LEAD Family Medtronic Inc.
Mounds View, MN 55112		 Reduction in frequency of environmental monitoring testing in specific manufacturing areas.
P920047/S065
2/13/14		 Blazer II Cardiac Ablation Catheter and Cable Boston Scientific Corporation
Maple Grove, MN 55311		 Equipment change to one of the ethylene oxide sterilization chambers.
P930039/S103
2/4/14		 CapSureFix Novus Lead Medtronic CRDM
Mounds View, MN 55112		 Alternate manufacturing facility of existing supplier, and utilization of Supplier Quality Management (SQM) as the incoming inspection control for thermoformed blister trays.
P930039/S104
2/27/14		 CAPSUREFIX Lead,  CAPSUREFIX NOVUS Lead Medtronic Inc.
Mounds View, MN 55112		 Reduction in frequency of environmental monitoring testing in specific manufacturing areas.
P940015/S031
2/12/14		 Synvisc Genzyme Corporation
Ridgefield, NJ 07657		 Change in final packaging equipment.
P950020/S067
2/13/14		 Flextome Cutting Balloon Dilatation Device Boston Scientific Corporation
Maple Grove, MN 55311		 Add a fixture to the laser used in the hypotube-corewire laser bonding step of the balloon catheter manufacturing process.
P950024/S058
2/27/14		 CAPSURE EPICARDIAL PACING Lead Medtronic Inc.
Mounds View, MN 55112		 Reduction in frequency of environmental monitoring testing in specific manufacturing areas.
P950029/S087
2/27/14		 Reply SR, Reply DR, Esprit SR, and Esprit DR Pacemakers Sorin CRM USA, Inc.
Arvada, CO 
80004		 Changes on the SMD electronic assembly line for additional cooling equipment.
P960058/S107
2/14/14		 HiResolution Bionic Ear System Advanced Bionics
Sylmar, CA
91342		 Automation of an in-process continuity test.
P970051/S115
2/21/14		 Nucleus 24 Cochlear Implant System Cochlear Americas
Centennial, CO 80111		 Additional circuit board supplier.
P980003/S046
2/13/14		 Chilli II Cooled Ablation Catheter and Cable Boston Scientific Corporation
Maple Grove, MN 55311		 Equipment change to one of the ethylene oxide sterilization chambers.
P980007/S033
2/3/14		 Architect Free PSA Abbott Laboratories
Abbott Park Lake, IL 
60064		 Change to the quality control testing used on in-process materials.
P980016/S456
2/4/14		 Evera S VR, Evera S DR, Evera XT VR, and Evera XT DR Implantable Cardioverter Defibrillators Medtronic, Inc.
Mounds View, MN 55112		 Change in the inspection and manufacturing processes in the cathode mix for the implantable pulse generator battery.
P980016/S457
2/18/14		 Evera Implantable Cardioverter Defibrillators Medtronic, Inc.
Mounds View, MN 55112		 Updates to the manufacturing software used to control the battery case-cover weld process.
P980016/S459
2/18/14		 Revo MRI IPG Medtronic, Inc.
Mounds View, MN 55112		 Software modifications for Distribution Control Sorter Tool (DCST) system for the devices.
P980016/S460
2/27/14		 Evera S DR/VR ICD, Evera XT DR/VR ICD; Maximo II ICD; Protecta ICD, Protecta XT ICD, Secura ICD, Virtuoso II DR/VR ICD Medtronic, Inc.
Mounds View, MN 55112		 Automated equipment for the Vacuum/Backfill and Laser Seam Weld process.
P980016/S461
2/27/14		 Evera S DR ICD; Evera S VR ICD; Evera XT DR ICD; Evera XT VR ICD; Maximo II ICD; Protecta ICD; Protecta XT ICD; Secura ICD; Virtuoso II DR/VR ICD Medtronic, Inc.
Mounds View, MN 55112		 New cure and pre-heat oven for the medical adhesive curing process for the devices.
P980016/S462
2/27/14		 Evera S DR ICD; Evera S VR ICD; Evera XT DR ICD; Evera XT VR ICD Medtronic CRDM
Mounds View, MN 55112		 Add an additional incoming inspection test of the raw material used to manufacture the capacitor feed through deformation elements for the devices.
P980022/S151
2/27/14		 Paradigm REAL-Time System, Paradigm REAL-Time Revel System Medtronic MiniMed
Northridge, CA 91325		 Change in the insulin pump case assembly manufacturing process at Medtronic Puerto Rico Operations Co. (MPROC) to receive pump cases directly from a supplier with a new keypad and overlay. The insulin pumps are components of the Paradigm REAL-Time System, Paradigm REAL-Time Revel System, and MiniMed 530G System.
P980035/S363
2/4/14		 Adapta, Versa, Sensia IPGs Medtronic CRDM
Mounds View, MN 55112		 Alternate manufacturing facility of existing supplier, and utilization of Supplier Quality Management (SQM) as the incoming inspection control for thermoformed blister trays.
P980035/S364
2/18/14		 Adapta, Versa, Sensia IPG; Advisa DR IPG; Advisa DR MRI IPG; Relia IPG Medtronic, Inc.
Mounds View, MN 55112		 Software modifications for Distribution Control Sorter Tool (DCST) system for the devices.
P980035/S365
2/27/14		 Adapta IPG, Versa IPG, Sensia IPG, Advisa DR, Advisa DR MRI IPG Medtronic, Inc.
Mounds View, MN 55112		 Automated equipment for the Vacuum/Backfill and Laser Seam Weld process.
P980035/S366
2/27/14		 Adapta, Versa, Sensia IPG; Advisa DR IPG; Advisa DR MRI IPG Medtronic, Inc.
Mounds View, MN 55112		 New cure and pre-heat oven for the medical adhesive curing process for the devices.
P980049/S091
2/27/14		 Paradym VR, Paradym DR, Paradym RF VR, and Paradym RF DR ICDs Sorin CRM USA, Inc.
Arvada, CO 
80004		 Changes on the SMD electronic assembly line for additional cooling equipment.
P980049/S092
2/27/14		 Paradym VR, Paradym DR, Paradym RF VR, and Paradym RF DR Implantable Cardioverter Defibrillators Sorin CRM USA, Inc.
Arveda, CO  
80004		 Change related to the laser welding process rework for a visual defect applicable to these implantable pulse generators.
P990013/S033
2/10/14		 STAAR Surgical Collamer® Intraocular Lenses STAAR Surgical Company
Monrovia, CA 91016		 New manufacturing filter.
P990023/S012
2/27/14		 Cellugel Ophthalmic Viscosurgical Device (OVD) Alcon Research, Ltd.
Fort Worth, TX 76134		 Use of a new method for the identification and determination of HydroxyPropylMethylCellulose (HPMC) in the Cellugel OVD.
P990027/S019
2/27/14		 Technolas 217a Excimer Laser and 217z Zyoptix Systems Technolas Perfect Vision GmbH
Munich, Bavaria 
Germany
80992		 Replacement of the capacitor and diagnostic monitor.
P990052/S024
2/13/14		 VIBRANT MED-EL Soundbridge System MED-EL Elektro-Medizinische Geräte GmbH
Innsbruck – Fürstenweg 77a
Austria 
A-6020		 Use of an alternate supplier of bond coating material, use of an alternate wire supplier, and changes to the sleeve manufacturing process.
P990075/S025
2/20/14		 Saline-Filled Breast Implants and Spectrum Breast Implants Mentor Worldwide, LLC
Santa Barbara, CA 93111		 Add an additional supplier for components used in the manufacture of Mentor’s Saline-Filled Breast Implants and Spectrum Breast Implants.
P010013/S052
2/25/14		 NovaSure Impedance Controlled Endometrial Ablation System Hologic, Inc.
Marlborough, MA 01752		 Inclusion of the updated Machine Operating Instructions.
P010015/S232
2/25/14		 Consulta CRT-P; Syncra CRT-P Medtronic, Inc.
Mounds View, MN 55112		 Software modifications for Distribution Control Sorter Tool (DCST) system for the devices.
P010015/S233
2/27/14		 Consulta CRT-P, Syncra CRT-P Medtronic, Inc.
Mounds View, MN 55112		 Modifying the start and end position of the weld sequence, correcting a synchronization issue in the equipment program, and modifying the associated work instructions for the middle bracket used with the devices.
P010030/S048
2/21/14		 LifeVest WCD 4000 Wearable Cardioverter Defibrillator Zoll Lifecor Corporation
Pittsburgh, PA 15238		 Implementation of the In Circuit Test (ICT) fixture for electrical testing of the Printed Circuit Assembly (PCA) of the LifeVest 4000 Battery Charger/ Modem’s Bedside PCA.
P010031/S418
2/4/14		 Brava, Viva S, and Viva XT Cardiac Resynchronization Therapy Defibrillators Medtronic, Inc.
Mounds View, MN 55112		 Change in the inspection and manufacturing processes in the cathode mix for the implantable pulse generator battery.
P010031/S419
2/18/14		 Viva/Brava Cardiac Resynchronization Therapy Defibrillators Medtronic, Inc.
Mounds View, MN 55112		 Updates to the manufacturing software used to control the battery case-cover weld process.
P010031/S421
2/18/14		 Brava CRT-D; Concerto II CRT-D; Consulta ICD; Maximo II CRT-D; Protecta CRT-D; Protecta XT CRT-D; Viva S CRT-D; Viva XT CRT-D Medtronic, Inc.
Mounds View, MN 55112		 Software modifications for Distribution Control Sorter Tool (DCST) system for the devices.
P010031/S422
2/27/14		 Brava CRT-D, Concerto II CRT-D, Consulta ICD, Maximo II CRT-D, Protecta CRT-D, Protecta XT CRT-D, Viva S CRT-D, Viva XT CRT-D Medtronic, Inc.
Mounds View, MN 55112		 Automated equipment for the Vacuum/Backfill and Laser Seam Weld process.
P010031/S423
2/27/14		 Brava CRT-D; Concerto II CRT-D Consulta ICD; Maximo II CRT-D; Protecta CRT-D; Protecta XT CRT-D; Viva S CRT-D; Viva XT CRT-D Medtronic, Inc.
Mounds View, MN 55112		 New cure and pre-heat oven for the medical adhesive curing process for the devices.
P010031/S424
2/27/14		 Brava CRT-D; Viva S CRT-D; Viva XT CRT-D Medtronic CRDM
Mounds View, MN 55112		 Add an additional incoming inspection test of the raw material used to manufacture the capacitor feed through deformation elements for the devices.
P020004/S091
2/21/14		 EXCLUDER AAA Endoprosthesis W.L. Gore & Associates
Flagstaff, AZ 
86001		 Implementation of an additional sewing machine for manufacture of the EXCLUDER AAA Endoprosthesis.
P020009/S115
2/14/14		 Express 2 Monorail and Over-the-Wire Boston Scientific Corporation
Maple Grove, MN 55311		 Equipment change to one of the ethylene oxide sterilization chambers.
P020009/S116
2/6/14		 Express/Express2™ Monorail® and OTW Coronary Stent System Boston Scientific Corporation
Maple Grove, MN 55311		 Replacement of a camera in the catheter inspection process.
P020025/S052
2/7/14		 Blazer Prime XP & Intellatip MiFi XP Temperature Ablation Catheters Boston Scientific Corporation
San Jose, CA 
95134		 Automate and move an extrusion process for the Blazer Prime XP & Intellatip MiFi XP Temperature Ablation Catheters to a different manufacturing line.
P020025/S053
2/13/14		 Blazer II XP Cardiac Ablation Catheter and Cable Boston Scientific Corporation
Maple Grove, MN 55311		 Equipment change to one of the ethylene oxide sterilization chambers.
P020045/S051
2/7/14		 Freezor Cryoablation Catheters, Freezor Xtra Surgical Cryoablation Device, Freezor Max Surgical Cryoablation Device Medtronic CryoCath LP
Quebec, Canada H9R 5Z8		 Changes to manufacturing equipment and manufacturing equipment software changes supporting a Windows 7 operating system upgrade.
P020045/S052
2/7/14		 Freezor, Freezor MAX and Freeze Xtra Cryoablation Devices Medtronic CryoCath LP
Quebec, Canada H9R 5Z8		 Two additional sterilization chambers in the Sterigenics EO facility in Toronto, Canada.
P020050/S016
2/20/14		 WaveLight EX500 Laser System Alcon Research, Ltd.
Fort Worth, TX 76134		 Addition of an alternate component supplier.
P020056/S024
2/14/14		 NATRELLE Silicone-Filled Breast Implants Allergan Medical
Goleta, CA 
93117		 Change in the sterilization validation method, including a change in the D-value of the biological indicators and a change in the validation protocol method.
P030002/S029
2/13/14		 Crystalens and Trulign Toric Intraocular Lens (IOLs) Bausch & Lomb
Irvine, CA 
92618		 Manufacturing change to the tumbling process.
P030005/S105
2/27/14		 INVIVE, INTUA CRT-Ps Boston Scientific Corporation
Saint Paul, MN 55112		 Add inspection criteria at the spot-welding step before spot-welding the feedthru wires to the connector blocks.
P030008/S014
2/20/14		 WaveLight EX500 Laser System Alcon Research, Ltd.
Fort Worth, TX 76134		 Addition of an alternate component supplier.
P030016/S026
2/10/14		 STAAR Surgical Implantable Collamer® Lenses for Myopia STAAR Surgical Company
Monrovia, CA 91016		 New manufacturing filter.
P030017/S189
2/25/14		 Precision Spectra Spinal Cord Stimulator System Boston Scientific Corporation
Valencia, CA
91355		 Utilize an alternate test equipment system for functionality testing.
P030025/S101
2/13/14		 TAXUS Express2 Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN 55311		 Equipment change to one of the ethylene oxide sterilization chambers.
P030036/S070
2/27/14		 SELECTSECURE Lead Family Medtronic Inc.
Mounds View, MN 55112		 Reduction in frequency of environmental monitoring testing in specific manufacturing areas.
P030050/S020
2/19/14		 SCULPTRA and SCULPTRA AESTHETIC Valeant Pharmaceuticals North America LLC
Bridgewater, NJ 08807		 Replacement of the radiation source and subsequent requalification of the radiation process at the firm’s contract sterilizer facility.
P030054/S256
2/6/14		 Unify, Unify Assura, Unify Quadra, and Quadra Assura Cardiac Resynchronization Therapy Defibrillators St. Jude Medical
Sylmar, CA 
91342		 Change in the hydrohone process.
P030054/S258
2/18/14		 Promote; Promote Accel; Promote RF; Promote Q; Promote Quadra; Promote+; Quadra Assura; Unify; Unify Assura; Unify Quadra St. Jude Medical
Sylmar, CA 
91342		 XTS Anode Foil Etching Additive for manufacturing of the high voltage capacitors for the devices.
P040016/S121
2/13/14		 VeriFLEX (Liberté) Coronary Stent System Boston Scientific Corporation
Maple Grove, MN 55311		 Equipment change to one of the ethylene oxide sterilization chambers.
P040016/S122
2/6/14		 VeriFLEX™ (Liberté®) Coronary Stent System Boston Scientific Corporation
Maple Grove, MN 55311		 Replacement of a camera in the catheter inspection process.
P040046/S006
2/14/14		 NATRELLE Highly Cohesive Silicone-Filled Breast Implants Allergan Medical
Goleta, CA 
93117		 Change in the sterilization validation method, including a change in the D-value of the biological indicators and a change in the validation protocol method.
P040047/S033
2/4/14		 Coaptite Injectable Implant Merz North America, Inc.
Franksville, WI  53126		 In-sourcing testing of a raw material component of the Coaptite product.
P050047/S034
2/11/14		 Juvéderm Hyaluronate Gel Implants Allergan
Goleta, CA 
93117		 Use of in-house laboratory for bacterial identification testing.
P050047/S035
2/21/14		 Juvéderm Hyaluronate Gel Implants Allergan
Goleta, CA 
93117		 Use of a temporary warehouse for the storage of raw materials, packaging items, and finished products.
P060006/S054
2/13/14		 Express SD Monorail Premounted Stent System Boston Scientific Corporation
Maple Grove, MN 55311		 Equipment change to one of the ethylene oxide sterilization chambers.
P060008/S108
2/13/14		 TAXUS Liberté Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN 55311		 Equipment change to one of the ethylene oxide sterilization chambers.
P060027/S058
2/27/14		 Paradym and Paradym RF CRT-Ds Sorin CRM USA, Inc.
Arvada, CO 
80004		 Changes on the SMD electronic assembly line for additional cooling equipment.
P060027/S059
2/27/14		 Paradym CRT-D and Paradym RF CRT-D Cardiac Resynchronization Therapy Defibrillators Sorin CRM USA, Inc.
Arveda, CO  
80004		 Change related to the laser welding process rework for a visual defect applicable to these implantable pulse generators.
P060033/S086
2/3/14		 Endeavor Sprint Zotarolimus Eluting Coronary Stent System Medtronic Vascular
Santa Rosa, CA 95403		 Changes to automate select analytical testing documentation processes.
P060033/S087
2/21/14		 Endeavor Sprint Zotarolimus Eluting Coronary Stent System Medtronic Vascular
Santa Rosa, CA 95403		 Introduce an upgraded laser ablation machine with integrated automated handling for the hypotube component.
P060037/S029
2/21/14		 NexGen LPS Flex / LPS-Mobile Bearing Knee Zimmer, Inc.
Warsaw, IN 
46581		 Change to modify the final cleaning process.
P070027/S038
2/26/14		 Talent Occluder with Occluder Delivery System Medtronic Vascular
Santa Rosa, CA 95403		 Duplicate the stent graft washing process and the interim packaging/ shipment of stent grafts from one approved stent graft manufacturing site to another.
P080006/S066
2/18/14		 Attain Ability LV Leads Medtronic, Inc.
Mounds View, MN 55112		 Minor changes associated with the connector label of the leads.
P090006/S013
2/5/14		 Complete SE Vascular Stent System Medtronic Vascular
Santa Rosa, CA 95403		 Manufacturing transfer of a critical manufacturing aid.
P090013/S127
2/4/14		 CapSureFix MRI Lead Medtronic CRDM
Mounds View, MN 55112		 Alternate manufacturing facility of existing supplier, and utilization of Supplier Quality Management (SQM) as the incoming inspection control for thermoformed blister trays.
P090013/S128
2/18/14		 Revo MRI IPG Medtronic, Inc.
Mounds View, MN 55112		 Software modifications for Distribution Control Sorter Tool (DCST) system for the devices.
P090013/S129
2/27/14		 CAPSUREFIX MRI Lead Medtronic Inc.
Mounds View, MN 55112		 Reduction in frequency of environmental monitoring testing in specific manufacturing areas.
P090013/S130
2/27/14		 Revo MRI IPG Medtronic, Inc.
Mounds View, MN 55112		 Automated equipment for the Vacuum/Backfill and Laser Seam Weld process.
P090013/S131
2/27/14		 Revo MRI IPG Medtronic, Inc.
Mounds View, MN 55112		 New cure and pre-heat oven for the medical adhesive curing process for the devices.
P100010/S033
2/7/14		 Artic Front Cardic Cryoablation Catheters, Artic Front Advance Cardiac Cryoablation Catheters, Freezor Max Cardiac Cryoab Medtronic CryoCath LP
Quebec, Canada H9R 5Z8		 Changes to manufacturing equipment and manufacturing equipment software changes supporting a Windows 7 operating system upgrade.
P100010/S034
2/7/14		 Artic Front and Artic Front Advance Cryoablation Catheters Medtronic CryoCath LP
Quebec, Canada H9R 5Z8		 Two additional sterilization chambers in the Sterigenics EO facility in Toronto, Canada.
P100018/S010
2/27/14		 Pipeline Embolization Device Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Irvine, CA 
92618		 Sterilization process change.
P100021/S033
2/26/14		 Endurant Stent Graft System Medtronic Vascular
Santa Rosa, CA 95403		 Duplicate the stent graft washing process and the interim packaging/ shipment of stent grafts from one approved stent graft manufacturing site to another.
P100023/S083
2/6/14		 ION Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN 55311		 Change to the delivery catheter assembly manufacturing process.
P100023/S084
2/13/14		 ION Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN 55311		 Equipment change to one of the ethylene oxide sterilization chambers.
P100023/S085
2/6/14		 ION™ Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN 55311		 Change to the foreign material removal step.
P100023/S086
2/6/14		 ION™ Paclitaxel- Eluting Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire Systems) Boston Scientific Corporation
Maple Grove, MN 55311		 Replacement of a camera in the catheter inspection process.
P100023/S087
2/13/14		 ION Paclitaxel-Eluting Platinum Chromium Coronary Stent System Boston Scientific Corporation
Maple Grove, MN 55311		 Add a fixture to the laser used in the hypotube-corewire laser bonding step of the balloon catheter manufacturing process.
P100026/S008
2/14/14		 NeuroPace RNS System NeuroPace, Inc.
Mountain View, CA 94043		 Update the hardware and software platform of Automated Test Equipment.
P100026/S009
2/21/14		 NeuroPace RNS System NeuroPace, Inc.
Mountain View, CA 94043		 Add an alternate supplier for the molded stylet retainer.
P100026/S010
2/25/14		 NeuroPace RNS System NeuroPace, Inc.
Mountain View, CA 94043		 Add a second supplier for the printed circuit assembly.
P100040/S016
2/26/14		 Valiant Thoracic Stent Graft with the Captivia Delivery System Medtronic Vascular
Santa Rosa, CA 95403		 Duplicate the stent graft washing process and the interim packaging/ shipment of stent grafts from one approved stent graft manufacturing site to another.
P100044/S015
2/11/14		 Propel and Propel Mini Sinus Implants Intersect ENT
Menlo Park, CA 94025		 Alternate supplier be cleared.
P100047/S034
2/6/14		 HeartWare Ventricular Assist System HeartWare, Inc.
Miami Lakes, FL 33014		 Implementation of a re-work process for the pumps.
P100047/S036
2/21/14		 HeartWare® Ventricular Assist System HeartWare, Inc.
Miami Lakes, FL 33014		 Use of an alternate supplier for an alternate MOSFET used in the HeartWare Ventricular Assist System.
P110002/S004
2/21/14		 LDR Spine Mobi-C Cervical Disc Prosthesis for use at One Level LDR Spine
Austin, TX 
78750		 Supplier change.
P110009/S004
2/21/14		 LDR Spine Mobi-C Cervical Disc Prosthesis for use at Two Levels LDR Spine
Austin, TX 
78750		 Supplier change.
P110010/S065
2/13/14		 PROMUS Element Plus Everolimus-Eluting Stent System Boston Scientific Corporation
Maple Grove, MN 55311		 Equipment change to one of the ethylene oxide sterilization chambers.
P110010/S066
2/6/14		 PROMUS Element™ Plus/ Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System Boston Scientific Corporation
Maple Grove, MN 55311		 Change to the foreign material removal step.
P110010/S067
2/6/14		 PROMUS® Element™ Plus/Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System Boston Scientific Corporation
Maple Grove, MN 55311		 Replacement of a camera in the catheter inspection process.
P110010/S068
2/13/14		 PROMUS Element Plus/Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System Boston Scientific Corporation
Maple Grove, MN 55311		 Add a fixture to the laser used in the hypotube-corewire laser bonding step of the balloon catheter manufacturing process.
P110010/S069
2/27/14		 PROMUS Element Plus/Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System Boston Scientific Corporation
Maple Grove, MN 55311		 Change to the environmental monitoring data collection process.
P110010/S070
2/27/14		 Promus PREMIER™ Everolimus-Eluting Platinum-Chromium Coronary Stent System Boston Scientific Corporation
Maple Grove, MN 55311		 Updates to the software and hardware of the balloon molding towers.
P110010/S071
2/27/14		 Promus PREMIER™ Everolimus-Eluting Platinum-Chromium Coronary Stent System Boston Scientific Corporation
Maple Grove, MN 55311		 Reduction in inspection wait time for a molded manifold component.
P110010/S072
2/27/14		 Promus PREMIER™ Everolimus-Eluting Platinum-Chromium Coronary Stent System   Boston Scientific Corporation
Maple Grove, MN 55311		 Use of new traceability/tracking software in the receiving inspection area.
P110010/S073
2/27/14		 Promus PREMIER™ Everolimus-Eluting Platinum-Chromium Coronary Stent System Boston Scientific Corporation
Maple Grove, MN 55311		 Software changes to update the manufacturing execution system.
P110010/S074
2/27/14		 Promus PREMIER™ Everolimus-Eluting Platinum-Chromium Coronary Stent System Boston Scientific Corporation
Maple Grove, MN 55311		 Change to the sterilization facility’s Central Monitoring System (CMS).
P110013/S033
2/3/14		 Resolute Integrity Zotarolimus Eluting Coronary Stent System Medtronic Vascular
Santa Rosa, CA 95403		 Changes to automate select analytical testing documentation processes.
P110033/S003
2/11/14		 Juvéderm Voluma XC Allergan
Goleta, CA 
93117		 Use of in-house laboratory for bacterial identification testing.
P110033/S004
2/21/14		 Juvéderm Voluma XC Allergan
Goleta, CA 
93117		 Use of a temporary warehouse for the storage of raw materials, packaging items, and finished products.
P110040/S003
2/5/14		 Complete SE Vascular Stent System Medtronic Vascular
Santa Rosa, CA 95403		 Manufacturing transfer of a critical manufacturing aid.
P110040/S004
2/28/14		 Complete SE Vascular Stent System Medtronic Vascular
Santa Rosa, CA 95403		 Multiple changes in the stent processing.
P110042/S026
2/7/14		 SQ-RX Subcutaneous Implantable Defibrillator (S-ICD) System Cameron Health, Inc.
San Clemente, CA 92673		 Implement a High Power Hybrid (HPH) Resistance Screening System and rework process at the HPH supplier.
P120010/S009
2/27/14		 MiniMed 530G System Medtronic MiniMed
Northridge, CA 91325		 Change in the insulin pump case assembly manufacturing process at Medtronic Puerto Rico Operations Co. (MPROC) to receive pump cases directly from a supplier with a new keypad and overlay. The insulin pumps are components of the Paradigm REAL-Time System, Paradigm REAL-Time Revel System, and MiniMed 530G System.

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