Medical Devices

February 2014 PMA Approvals

A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available.

PMA Original Approvals

APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
P090031
2/25/14
MONOVISC™ Injectable Intra-articular DeviceAnika 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 APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
P830061/S086
2/18/14
180-Day
CapSure Sense Family of LeadsMedtronic, 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 LensesCoopervision, 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 SystemMedtronic 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 MonitorMedtronic, 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
DDMAMedtronic 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, SyncraMedtronic, 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 ProfilerBD 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 FamilySt. 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 SystemEthicon, 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 10.0Hologic, 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, VirtuosoMedtronic, 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 SoftwareMedtronic 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, VirtuosoMedtronic, 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, KappaMedtronic, 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, KappaMedtronic, 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 BioprosthesisMedtronic, 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, SyncraMedtronic, 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 SystemsMedtronic, 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 HeadMedtronic, 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, VivaMedtronic, 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 SoftwareMedtronic 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, VivaMedtronic, 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 SystemBoston 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 FibrillationBiosense 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 ImplantsMentor 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 TachycardiaBiosense 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 FillerMerz 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 ParticlesMedafor 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 HemostatStryker 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 FillerMerz 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 KneeZimmer 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 PumpFlowonix 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 SystemIntegra Lifesciences Corporation
Bedford, MA
01801
Approval of the post-approval study protocol.
P090013/S112
2/14/14
180-Day
Revo MRIMedtronic, 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 MRIMedtronic, 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 SystemLeica 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 GelSalix 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 1.0Otsuka 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 SystemNeuropace, Inc.
Mountain View, CA
94043
Approval of the post-approval study protocol.
P100026/S004
2/24/14
180-Day
Neuropace RNS SystemNeuropace, Inc.
Mountain View, CA
94043
Approval of the post-approval study protocol.
P100026/S005
2/18/14
180-Day
Neuropace RNS SystemNeuropace, Inc.
Mountain View, CA
94043
Approval of the post-approval study protocol.
P100026/S006
2/14/14
180-Day
Neuropace RNS SystemNeuropace, 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 SystemHeartware, Inc.
Miami, FL
33014
Approval of the post-approval study protocol.
P100047/S033
2/13/14
Real-Time
HeartWare Ventricular Assist SystemHeartware, 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 SystemGE 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 SystemMedtronic 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 SystemMedtronic 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 SystemAbbott 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 SystemDexcom 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 SystemDexcom, 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 APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
N970003/S158
2/27/14
FORMIO, VITALIO, ADVANTIO, INGENIO PacemakersBoston 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 LeadMedtronic 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 LeadMedtronic 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 CircuitBunnell, 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 LeadsMedtronic Inc.
Mounds View, MN 55112
Reduction in frequency of environmental monitoring testing in specific manufacturing areas.
P890003/S302
2/27/2017
CAPSURE LeadMedtronic 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 GuidewireBoston 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 SLEEVEMedtronic Inc.
Mounds View, MN 55112
Reduction in frequency of environmental monitoring testing in specific manufacturing areas.
P910007/S042
2/3/14
Architect Total PSAAbbott 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 DefibrillatorsSt. 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 VRSt. 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 FamilyMedtronic 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 CableBoston Scientific Corporation
Maple Grove, MN 55311
Equipment change to one of the ethylene oxide sterilization chambers.
P930039/S103
2/4/14
CapSureFix Novus LeadMedtronic 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 LeadMedtronic Inc.
Mounds View, MN 55112
Reduction in frequency of environmental monitoring testing in specific manufacturing areas.
P940015/S031
2/12/14
SynviscGenzyme Corporation
Ridgefield, NJ 07657
Change in final packaging equipment.
P950020/S067
2/13/14
Flextome Cutting Balloon Dilatation DeviceBoston 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 LeadMedtronic 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 PacemakersSorin 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 SystemAdvanced Bionics
Sylmar, CA
91342
Automation of an in-process continuity test.
P970051/S115
2/21/14
Nucleus 24 Cochlear Implant SystemCochlear Americas
Centennial, CO 80111
Additional circuit board supplier.
P980003/S046
2/13/14
Chilli II Cooled Ablation Catheter and CableBoston Scientific Corporation
Maple Grove, MN 55311
Equipment change to one of the ethylene oxide sterilization chambers.
P980007/S033
2/3/14
Architect Free PSAAbbott 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 DefibrillatorsMedtronic, 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 DefibrillatorsMedtronic, 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 IPGMedtronic, 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 ICDMedtronic, 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 ICDMedtronic, 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 ICDMedtronic 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 SystemMedtronic 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 IPGsMedtronic 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 IPGMedtronic, 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 IPGMedtronic, 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 IPGMedtronic, 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 ICDsSorin 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 DefibrillatorsSorin 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 LensesSTAAR 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 SystemsTechnolas Perfect Vision GmbH
Munich, Bavaria
Germany
80992
Replacement of the capacitor and diagnostic monitor.
P990052/S024
2/13/14
VIBRANT MED-EL Soundbridge SystemMED-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 ImplantsMentor 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 SystemHologic, Inc.
Marlborough, MA 01752
Inclusion of the updated Machine Operating Instructions.
P010015/S232
2/25/14
Consulta CRT-P; Syncra CRT-PMedtronic, 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-PMedtronic, 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 DefibrillatorZoll 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 DefibrillatorsMedtronic, 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 DefibrillatorsMedtronic, 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-DMedtronic, 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-DMedtronic, 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-DMedtronic, 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-DMedtronic 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 EndoprosthesisW.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-WireBoston 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 SystemBoston 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 CathetersBoston 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 CableBoston 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 DeviceMedtronic 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 DevicesMedtronic 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 SystemAlcon Research, Ltd.
Fort Worth, TX 76134
Addition of an alternate component supplier.
P020056/S024
2/14/14
NATRELLE Silicone-Filled Breast ImplantsAllergan 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-PsBoston 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 SystemAlcon Research, Ltd.
Fort Worth, TX 76134
Addition of an alternate component supplier.
P030016/S026
2/10/14
STAAR Surgical Implantable Collamer® Lenses for MyopiaSTAAR Surgical Company
Monrovia, CA 91016
New manufacturing filter.
P030017/S189
2/25/14
Precision Spectra Spinal Cord Stimulator SystemBoston 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 SystemBoston Scientific Corporation
Maple Grove, MN 55311
Equipment change to one of the ethylene oxide sterilization chambers.
P030036/S070
2/27/14
SELECTSECURE Lead FamilyMedtronic Inc.
Mounds View, MN 55112
Reduction in frequency of environmental monitoring testing in specific manufacturing areas.
P030050/S020
2/19/14
SCULPTRA and SCULPTRA AESTHETICValeant 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 DefibrillatorsSt. 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 QuadraSt. 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 SystemBoston 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 SystemBoston 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 ImplantsAllergan 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 ImplantMerz 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 ImplantsAllergan
Goleta, CA
93117
Use of in-house laboratory for bacterial identification testing.
P050047/S035
2/21/14
Juvéderm Hyaluronate Gel ImplantsAllergan
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 SystemBoston 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 SystemBoston 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-DsSorin 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 DefibrillatorsSorin 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 SystemMedtronic Vascular
Santa Rosa, CA 95403
Changes to automate select analytical testing documentation processes.
P060033/S087
2/21/14
Endeavor Sprint Zotarolimus Eluting Coronary Stent SystemMedtronic 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 KneeZimmer, Inc.
Warsaw, IN
46581
Change to modify the final cleaning process.
P070027/S038
2/26/14
Talent Occluder with Occluder Delivery SystemMedtronic 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 LeadsMedtronic, Inc.
Mounds View, MN 55112
Minor changes associated with the connector label of the leads.
P090006/S013
2/5/14
Complete SE Vascular Stent SystemMedtronic Vascular
Santa Rosa, CA 95403
Manufacturing transfer of a critical manufacturing aid.
P090013/S127
2/4/14
CapSureFix MRI LeadMedtronic 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 IPGMedtronic, Inc.
Mounds View, MN 55112
Software modifications for Distribution Control Sorter Tool (DCST) system for the devices.
P090013/S129
2/27/14
CAPSUREFIX MRI LeadMedtronic Inc.
Mounds View, MN 55112
Reduction in frequency of environmental monitoring testing in specific manufacturing areas.
P090013/S130
2/27/14
Revo MRI IPGMedtronic, Inc.
Mounds View, MN 55112
Automated equipment for the Vacuum/Backfill and Laser Seam Weld process.
P090013/S131
2/27/14
Revo MRI IPGMedtronic, 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 CryoabMedtronic 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 CathetersMedtronic 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 DeviceMicro Therapeutics, Inc. d/b/a ev3 Neurovascular
Irvine, CA
92618
Sterilization process change.
P100021/S033
2/26/14
Endurant Stent Graft SystemMedtronic 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 SystemBoston Scientific Corporation
Maple Grove, MN 55311
Change to the delivery catheter assembly manufacturing process.
P100023/S084
2/13/14
ION Paclitaxel-Eluting Coronary Stent SystemBoston 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 SystemBoston 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 SystemBoston 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 SystemNeuroPace, Inc.
Mountain View, CA 94043
Update the hardware and software platform of Automated Test Equipment.
P100026/S009
2/21/14
NeuroPace RNS SystemNeuroPace, Inc.
Mountain View, CA 94043
Add an alternate supplier for the molded stylet retainer.
P100026/S010
2/25/14
NeuroPace RNS SystemNeuroPace, 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 SystemMedtronic 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 ImplantsIntersect ENT
Menlo Park, CA 94025
Alternate supplier be cleared.
P100047/S034
2/6/14
HeartWare Ventricular Assist SystemHeartWare, Inc.
Miami Lakes, FL 33014
Implementation of a re-work process for the pumps.
P100047/S036
2/21/14
HeartWare® Ventricular Assist SystemHeartWare, 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 LevelLDR Spine
Austin, TX
78750
Supplier change.
P110009/S004
2/21/14
LDR Spine Mobi-C Cervical Disc Prosthesis for use at Two LevelsLDR Spine
Austin, TX
78750
Supplier change.
P110010/S065
2/13/14
PROMUS Element Plus Everolimus-Eluting Stent SystemBoston 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 SystemBoston 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 SystemBoston 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 SystemBoston 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 SystemBoston 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 SystemBoston 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 SystemBoston 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 SystemBoston 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 SystemBoston 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 SystemMedtronic Vascular
Santa Rosa, CA 95403
Changes to automate select analytical testing documentation processes.
P110033/S003
2/11/14
Juvéderm Voluma XCAllergan
Goleta, CA
93117
Use of in-house laboratory for bacterial identification testing.
P110033/S004
2/21/14
Juvéderm Voluma XCAllergan
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 SystemMedtronic Vascular
Santa Rosa, CA 95403
Manufacturing transfer of a critical manufacturing aid.
P110040/S004
2/28/14
Complete SE Vascular Stent SystemMedtronic Vascular
Santa Rosa, CA 95403
Multiple changes in the stent processing.
P110042/S026
2/7/14
SQ-RX Subcutaneous Implantable Defibrillator (S-ICD) SystemCameron 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 SystemMedtronic 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.

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

Page Last Updated: 06/25/2014
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