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PMA Final Decisions for August 2012

Wed, 10/10/2012 - 12:00am
U.S. Food & Drug Administration

Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions. This list is generated on a monthly basis.

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

None.

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P910023/S290
8/9/12
135-Day
Current and Fortify Families of ICDs St. Jude Medical
Sylmar, CA
91342
Approval for the removal of a plasma cleaning step for hybrid surface preparation.
P910023/S295
8/9/12
180-Day
Version 6.1 Software for Merlin.net System St. Jude Medical
Sunnyvale, CA
94086
Approval of Model MN5000 version 6.1 software to be used with the Merlin.net System and for the Model EX2000 version 6.1 software to be used on Merlin@home devices.
P910066/S026
8/10/12
180-Day
OL1000 SM, OL1000 MED, Spinalogic, and Spinalogic, E-coil Bone Growth Stimulators DJO, LLC
Vista, CA
92081
Approval for a manufacturing site and acceptance activities located in Vista, California.
P910071/S014
8/31/12
Special
ADATO® SIL-OL 5000 Silicone Oil Bausch & Lomb, Inc.
Aliso Viejo, CA
92656
Approval for the labeling changes to the Directions for Use (DFU). The DFU was revised to include safety information regarding the use of CO 2 lasers in instances where silicone oil may have migrated out of the eye and formed lesions in the conjunctiva or eyelid.
P930036/S004
8/14/12
135-Day
ADVIA Centaur/XP and Centaur CP AFP Reagents and Calibrators Siemens Healthcare Diagnostics, Inc.
East Walpole, MA
02032
Approval for the implementation of a Lot Specific Master Curve in the quality control testing of the anti-AFP antibody.
P950009/S016
8/30/12
Real-Time
BD FocalPoint™ Slide Profiler BD Diagnostics
Durham, NC
27703
Approval for change of the Scan Controller Board for the device.
P950037/S109
8/28/12
Real-Time
Reliaty Pacing System Analyzer Biotronik, Inc.
Lake Oswego, OR
97035
Approval for firmware modifications and labeling updates to the devices.
P950037/S110
8/8/12
Real-Time
PSW 1202.U for Renamic & ICS 3000 Biotronik, Inc.
Lake Oswego, OR
97035
Approval for updated software version PSW 1202.U.
P960004/S053
8/2/12
Real-Time
FINELINE II and ThinLine II Pacing Leads Boston Scientific
St. Paul, MN
55112
Approval for an alternate primer material.
P960009/S149
8/24/12
Real-Time
Activa Implantable Neurostimulators Medtronic Neuromodulation
Minneapolis, MN
55432
Approval for eliminating the external parylene coating from the
following Implantable Neurostimulators: Activa RC Model 37612, Activa PC Model 37601,
Activa SC Model 37602 and Activa SC Model 37603.
P960058/S096
8/20/12
135-Day
Harmony HiResolution Bionic Ear System, HiRes 90K Advanced Bionics
Sylmar, CA
91342
Approval for the change in fabrication line for the Analog Integrated Circuit (AIC).
D970003/S138
8/29/12
Real-Time
ZOOMVIEW Programmer Software Application v1.08 Boston Scientific
St. Paul, MN
55112
Approval for Model 2869 ZOOMVIEW Programmer Software Application v1.08
P990020/S047
8/16/12
135-Day
Aneurx Advantage Stent Graft with Xcelerant Hydro Delivery System Medtronic Vascular, Inc.
Santa Rosa, CA
95403
Approval for a change to automate the information management system.
P990046/S026
8/13/12
180-Day
Open Pivot Heart Valve Medtronic, Inc.
Minneapolis, MN
55432
Approval for a manufacturing site located at Biotest Laboratories in Brooklyn Park, Minnesota.
P990081/S012
8/21/12
Real-Time
PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody Ventana Medical Systems, Inc.
Tucson, AZ
85755
Approval for an extension of shelf life of the iView DAB detection kit and the ultraView DAB detection kit for the device.
P000009/S050
8/8/12
Real-Time
PSW 1202.U for Renamic & ICS 3000 Biotronik, Inc.
Lake Oswego, OR
97035
Approval for updated software version PSW 1202.U.
P000053/S041
8/21/12
180-Day
AMS Sphincter 800® Urinary Prosthesis with InhibiZone® Antibiotic Surface Treatment American Medical Systems
Minnetonka, MN
55343
Approval for revision of the amount of rifampin and minocycline specified in the
Instruction for use and the Operating Room Manual.
P000054/S028
8/3/12
135-Day
Infuse Bone Graft/LT-Cage Lumbar Tapered Fusion, Infuse Bone Graft Medtronic Sofamor Danek
Memphis, TN
38132
Approval for changes to tests performed as part of the ongoing drug product stability program for rhBMP-2 (dibotermin alfa).
P000054/S030
8/3/12
135-Day
INFUSE® Bone Graft Medtronic Sofamor Danek
Memphis, TN
38132
Approval for the substitution of a quality control test.
P000058/S041
8/3/12
135-Day
Infuse Bone Graft/LT-Cage Lumbar Tapered Fusion, Infuse Bone Graft Medtronic Sofamor Danek
Memphis, TN
38132
Approval for changes to tests performed as part of the ongoing drug product stability program for rhBMP-2 (dibotermin alfa).
P000058/S043
8/3/12
135-Day
INFUSE® Bone Graft/LT-Cage Lumbar Tapered Fusion Medtronic Sofamor Danek
Memphis, TN
38132
Approval for the substitution of a quality control test.
P010014/S036
8/2/12
Special
Oxford® Partial Knee System Biomet Manufacturing Corporation
Warsaw, IN
46581
Approval for updates to the package insert which included the following: strengthening and clarification of the importance of following the surgical technique, additional wording to clarify a precaution to the end user, expanded language for a possible adverse event about foreign material sensitivity and reformatting of the Magnetic Resonance (MR) section.
P010030/S035
8/15/12
Real-Time
LifeVest Wearable Defibrillator ZOLL Lifecor Corporation
Pittsburgh, PA
15238
Approval for minor hardware updates to lead-free components for the device.
P010032/S057
8/24/12
Real-Time
Eon Mini Implantable Pulse Generators (IPG) Neurostimulation System St. Jude Medical
Plano, TX
75024
Approval for a change to the internal battery housing material from titanium to 304L stainless steel.
P010047/S019
8/23/12
Real-Time
NeoMend ProGEL Pleural Air Leak Sealant NeoMend, Incorporated
Irvine, CA
92618
Approval for an extension of the refrigerated shelf life of the device.
P020045/S044
8/24/12
Real-Time
Cryoconsole Medtronic CryoCath LP
Quebec, Canada
H9R 5Z8
Approval for changes related to updating for compliance to IEC
60601-1 3rd Edition standards, removal of the floppy disk drive, and related labeling updates.
P020047/S046
8/20/12
180-Day
Multi-Link 8 and Multi-Link 8 LL Coronary Stent Systems (CSS) Abbott Vascular
Temecula, CA
92591
Approval for a sterilization site located in
Tipperary, Ireland .
P030005/S086
8/29/12
Real-Time
ZOOMVIEW Programmer Software Application v1.08 Boston Scientific
St. Paul, MN
55112
Approval for Model 2869 ZOOMVIEW Programmer Software Application v1.08
P030009/S061
8/16/12
135-Day
Driver, Micro-Driver and Integrity Coronary Stent Systems Medtronic Vascular, Inc.
Santa Rosa, CA
95403
Approval for a change to automate the information management system.
P030011/S015
8/10/12
Real-Time
SynCardia Companion 2 Driver System SynCardia Systems, Inc.
Tucson, AZ
85713
Approval for a change in the pressure limit range for the external air pressure regulator of the device.
P030011/S016
8/20/12
180-Day
SynCardia Companion 2 Driver System SynCardia Systems, Inc.
Tucson, AZ
85713
Approval of the post-approval study protocol.
P030054/S217
8/9/12
135-Day
Promote and Unify Families of CRT-Ds St. Jude Medical
Sylmar, CA
91342
Approval for the removal of a plasma cleaning step for hybrid surface preparation.
P030054/S223
8/9/12
180-Day
Version 6.1 Software for Merlin.net and Version 6.1 Software for Merlin@home St. Jude Medical
Sunnyvale, CA
94086
Approval of Model MN5000 version 6.1 software to be used with the Merlin.net System and for the Model EX2000 version 6.1 software to be used on Merlin@home devices.
P040002/S038
8/22/12
Real-Time
AFX AAA Endovascular System Endologix, Inc.
Irvine, CA
92618
Approval for stand-alone delivery systems for the straight and tapered limb extension stent grafts and for the flared limb extensions grafts. The device, as modified, will be marketed under the trade name AFX Stand-Alone Limb Extension Delivery System as an accessory to the AFX AAA Endovascular System which is indicated for endovascular treatment in patients with AAA.
P040012/S044
8/24/12
180-Day
RX Acculink Carotid Stent System Abbott Vascular
Santa Clara, CA
95054
Approval to update the labeling with long term CREST study results.
P040012/S046
8/2/12
180-Day
Standard Risk Indication RX Acculink® Carotid Stent System CANOPY Trial Abbott Vascular Inc.
Santa Clara, CA
95054
Approval of the post-approval study for the device.
P040014/S019
8/22/12
135-Day
Therapy Cardiac Ablation System St. Jude Medical
Irvine, CA
92614
Approval for an additional vendor of a generator component.
P040021/S022
180-Day
8/30/12
Biocor and Biocor Supra Valves St. Jude Medical
St. Paul, MN
55117
Approval of the post-approval study protocol.
P040024/S056
8/30/12
Panel-Track
Restylane L Injectable Gel Medicis Aesthetics Holding Incorporated
Scottsdale, AZ
85256
Approval for Restylane L Injectable Gel. This device is indicated for: 1) mid-to-deep dermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds; and 2) submucosal implantation for lip augmentation in patients over the age of 21.
P040024/S062
8/6/12
Real-Time
Restylane L and Perlane L Injectable Gel Medicis Global Services Corporation
Scottsdale, AZ
85256
Approval for an extension to the expiration date of the Restylane L and Perlane L Injectable Gels (0.5 and 1.0 mL) from 24 months to 36 months.
P040042/S024
8/22/12
135-Day
Therapy Dual 8 Cardiac Ablation System St. Jude Medical
Irvine, CA
92614
Approval for an additional vendor of a generator component.
P050012/S045
8/17/12
180-Day
Dexcom Color Continuous Glucose Monitoring System Dexcom, Inc.
San Diego, CA
92121
Approval for: 1) the addition of new components to the Global Transmitter/ Global Receiver system allowing communication at 2.4 GHz; 2) minor modifications to the Applicator bail and safety card; and 3) updates to the optional Data Manager software that is provided with the Seven Plus CGM System. The device, as modified, will be marketed under the trade name Dexcom Color Continuous Glucose Monitoring (CGM) System, and is a glucose-monitoring device indicated for detecting and tracking glucose trends and patterns to aid in the detection of episodes of hyperglycemia and hypoglycemia in adults with diabetes. The system is intended for single patient use and requires a prescription.
P050023/S054
8/8/12
Real-Time
PSW 1202.U for Renamic & ICS 3000 Biotronik, Inc.
Lake Oswego, OR
97035
Approval for updated software version PSW 1202.U.
P050027/S003
8/27/12
Real-Time
Karl Storz Photodynamic
D-Light C (PDD) System
Karl Storz Endoscopy-America, Inc.
El Segundo, CA
90245
Approval for an alternate sterilization method, STERRAD NX, for the fluid light cable device component within the device.
P050039/S008
8/17/12
135-Day
Novation Ceramic Articulation Hip System Exactech, Inc.
Gainesville, FL
32653
Approval for requested changes to the Blend/Polish Work Instruction for the Novation Splined Stems.
P050053/S019
8/3/12
135-Day
Infuse Bone Graft/LT-Cage Lumbar Tapered Fusion, Infuse Bone Graft Medtronic Sofamor Danek
Memphis, TN
38132
Approval for changes to tests performed as part of the ongoing drug product stability program for
rhBMP-2 (dibotermin alfa).
P050053/S021
8/3/12
135-Day
INFUSE® Bone Graft Medtronic Sofamor Danek
Memphis, TN
38132
Approval for the substitution of a quality control test.
P060019/S020
8/22/12
135-Day
Therapy Cool Path Ablation Catheter and IBI RF Ablation Generator St. Jude Medical
Irvine, CA
92614
Approval for an additional vendor of a generator component.
P060033/S070
8/16/12
135-Day
Endeavor Sprint Zotarolimus-Eluting Coronary Stent System Medtronic Vascular, Inc.
Santa Rosa, CA
95403
Approval for a change to automate the information management system.
P060039/S033
8/16/12
180-Day
Attain StarFix Lead Medtronic, Inc.
Mounds View, CA
55112
Approval of the post-approval study protocol.
P070007/S035
8/16/12
135-Day
Talent Thoracic Stent Graft System with the Xcelerant and Captivia Delivery System Medtronic Vascular, Inc.
Santa Rosa, CA
95403
Approval for a change to automate the information management system.
P070008/S033
8/8/12
Real-Time
PSW 1202.U for Renamic & ICS 3000 Biotronik, Inc.
Lake Oswego, OR
97035
Approval for updated software version PSW 1202.U.
P070027/S034
8/16/12
135-Day
Talent Abdominal Stent Graft with Xcelerant Hydro Delivery System Medtronic Vascular, Inc.
Santa Rosa, CA
95403
Approval for a change to automate the information management system.
P090006/S008
8/16/12
135-Day
Complete SE Vascular Stent System Medtronic Vascular, Inc.
Santa Rosa, CA
95403
Approval for a change to automate the information management system.
P090012/S001
8/8/12
180-Day
MelaFind Mela Sciences, Inc.
Irvington, NY
10533
Approval of the post-approval study protocol.
P090016/S002
8/10/12
Real-Time
Belotero Balance Merz Aesthetics, Inc.
Franksville, WI
53126
Approval for a modification to the Belotero Balance Instructions for Use to include 27 gauge needles as an option for injection.
P090022/S013
8/16/12
Special
Softec HD Posterior Chamber Intraocular Lens (IOL) Lenstec, Inc.
St. Petersburg, FL
33716
Approval for a modification to the directions for use to include a warning that enhances the safety in the use of the device.
P100010/S017
8/24/12
Real-Time
Cryoconsole Medtronic CryoCath LP
Quebec, Canada
H9R 5Z8
Approval for changes related to updating for compliance to IEC
60601-1 3rd Edition standards, removal of the floppy disk drive, and related labeling updates.
P100021/S015
8/16/12
135-Day
Endurant Stent Graft System Medtronic Vascular, Inc.
Santa Rosa, CA
95403
Approval for a change to automate the information management system.
P100023/S033
8/20/12
180-Day
ION Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Approval of the post-approval study protocol.
P100023/S038
8/16/12
135-Day
ION Paclitaxel-Eluting Platinum Chromium Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Approval for hardware and software changes to the catheter port manufacturing process.
P100029/S014
8/8/12
Special
Trifecta ™ Valve St. Jude Medical
St. Paul, MN
55117
Approval for adding an inspection for the maximum length for certain flaws where the depth cannot be accurately assessed.
P100040/S007
8/16/12
135-Day
Valiant Thoracic Stent Graft with the Captivia Delivery System Medtronic Vascular, Inc.
Santa Rosa, CA
95403
Approval for a change to automate the information management system.
P100041/S008
8/20/12
180-Day
Edwards SAPIEN™ Transcatheter Heart Valve and Accessories, RetroFlex™ Balloon Catheter and Crimper Edwards Lifesciences, LLC
Irvine, CA
92614
Approval to add the Edwards Transcatheter Balloon Catheters, Models 9350BC20 and 9350BC23 with a working balloon length of 4 cm, and to add some new control environments at the Draper facility in Draper, Utah to accommodate the manufacture of these catheters at that facility.
P100046/S001
8/15/12
180-Day
AtriCure Synergy Ablation System AtriCure, Inc.
Northborough, MA
01532
Approval of the post-approval study protocol.
P110010/S010
8/16/12
135-Day
PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Approval for hardware and software changes to the catheter port manufacturing process.
P110010/S020
8/24/12
Promus Element Plus Everolimus-Eluting Chromium Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Approval of the post-approval study protocol.
P110010/S021
8/23/12
180-Day
PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Approval of the post-approval study protocol.
P110011/S002
8/16/12
135-Day
Assurant Cobalt Iliac Balloon-Expandable Stent Medtronic Vascular, Inc.
Santa Rosa, CA
95403
Approval for a change to automate the information management system.
P110013/S001
8/16/12
135-Day
Resolute Integrity and Resolute Microtrac Coronary Stent System Medtronic Vascular, Inc.
Santa Rosa, CA
95403
Approval for a change to automate the information management system.
P110019/S014
8/20/12
180-Day
Xience Prime and Xience Prime LL Everolimus Eluting Coronary Stent Systems Abbott Vascular
Temecula, CA
92590
Approval for a sterilization site located in
Tipperary . Ireland.
P110019/S023
8/6/12
Real-Time
Xience Prime and Xience Prime LL Everolimus Eluting Coronary Stent System Abbott Vascular
Temecula, CA
92590
Approval for updating labeling for the Xience Prime Everolimus Eluting Coronary Stent System to reflect a 24 month shelf life.

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
P810031/S045
8/9/12
Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon, Healon GV and Healon5 Products Abbott Medical Optics, Inc.
Santa Ana, CA
92705
Replacement of an autoclave.
P830061/S077
8/30/12
CapSure Leads, Vitatron Crystalline Leads, and Vitatron Excellence PS+
Leads
Medtronic, Inc.
Mounds View, MN
55112
Modifications to a controlled environment.
P840001/S218
8/1/12
Restore Family of Implantable of Neurostimulators Medtronic Neuromodulation
Minneapolis, MN
55432
A change to the final functional test.
P840001/S220
8/10/12
SCS Extensions, SCS Temporary Leads (for Screening), SCS Leads 1x8 Family, SCS Leads Pisces Family and SCS Leads Specify Family Medtronic Neuromodulation
Minneapolis, MN
55432
Addition of a duplicate EtO Sterilization System.
P840001/S222
8/1/12
RestoreSensor Implantable Neurostimulator (INS) Medtronic Neuromodulation
Minneapolis, MN
55432
Design change to the post sterilization test software.
P840001/S224
8/22/12
Itrel 3, Synergy, Synergy Versitrel, Itrel 4, and Pocket Adaptors Medtronic Neuromodulation
Minneapolis, MN
55432
Addition of another supplier for the Inner Seal Silicone Component
117988-001.
P850089/S089
8/30/12
CapSure SP Novus Leads, CapSure SP Z Leads, CapSure Z Novus Leads and Impulse Il Leads Medtronic, Inc.
Mounds View, MN
55112
Modifications to a controlled environment.
P860004/S173
8/21/12
Synchromed II Infusion Pump Medtronic Neuromodulation
Minneapolis, MN
55432
Implementation of new package of sealing equipment.
P860004/S174
8/21/12
Synchromed II Infusion Pump Medtronic Neuromodulation
Minneapolis, MN
55432
Implementation of a new mold for a kit component.
P890003/S255
8/30/12
CapSure Leads and Prodigy IPG Medtronic, Inc.
Mounds View, MN
55112
Modifications to a controlled environment.
P900033/S022
8/22/12
Integra Dermal Regeneration Template Integra LifeSciences Corporation
Plainsboro, NJ
08536
Changes to the cleaning processes associated with the production equipment.
P900033/S023
8/14/12
Integra Dermal Regeneration Template Integra LifeSciences, Corporation
Plainsboro, NJ
08536
Improvements to the Water for Injection system associated with the production of the device.
P900033/S024
8/24/12
Integra Dermal Regeneration Template Integra LifeSciences, Corporation
Plainsboro, NJ
08536
Change in the inspection process for the manufacturing equipment.
P900033/S025
8/24/12
Integra Dermal Regeneration Template Integra LifeSciences, Corporation
Plainsboro, NJ
08536
Replacement of the air handling unit within a manufacturing suite.
P900061/S115
8/30/12
End Cap, Epicardial Patch Lead, Sizing Sleeve and Upsizing Sleeve Medtronic, Inc.
Mounds View, MN
55112
Modifications to a controlled environment.
P910007/S035
8/29/12
ARCHITECT TOTAL PSA Abbott Laboratories
Abbott Park, IL
60064
Change to the manufacturing material used to filter the common accessories.
P910023/S299
8/22/12
Fortify VR DF-4 ICD’s St. Jude Medical
Sylmar, CA
91342
Change to the tooling used during the routing step of the manufacturing process for the feedthru.
P910023/S300
8/30/12
Current, Fortify, Ellipse, Fortify Assura Family of ICD Devices St. Jude Medical
Sylmar, CA
91342
Addition of an alternate supplier for a seal component.
P910056/S012
8/31/12
enVista One Piece Hydrophobic Acrylic Lens Bausch & Lomb
Aliso Viejo, CA
92656
Alternate milling site and an alternate source for a material used for the manufacturing of the lenses.
P920015/S094
8/30/12
"Y" adaptor/ extender kit, DF-1 connector port pin plug, IS-1 connector
port pin plug kit, Lead adaptor, Sprint Quattro Lead, Subcutaneous Lead
and Transvene SVC Lead
Medtronic, Inc.
Mounds View, MN
55112
Modifications to a controlled environment.
P920023/S031
8/2/12
AMS UroLume Endoprosthesis American Medical Systems, Inc.
Minnetonka, MN
55343
Change in the label database server and a labeling software revision to the NiceLabel System.
P930014/S063
8/9/12
AcrySof Posterior Chamber Intraocular Lenses Alcon Laboratories, Inc.
Fort Worth, TX
76134
Implementation of a modified validated curing cycle.
P930039/S069
8/6/12
CapSureFix Novus Lead, Vitatron Crystalline Leads Medtronic, Inc.
Mounds View, MN
55112
Alternate suppliers of molded silicone components.
P930039/S070
8/15/12
CapSureFix Lead Medtronic, Inc.
Mounds View, MN
55112
Changes to the laser weld parameters used for the connector pin to coil laser weld process.
P930039/S071
8/30/12
CapSurefix Lead, CapSureFix Novus Lead, Surefix Lead and Torque Clip Device and Vitatron Crystalline Leads Medtronic, Inc.
Mounds View, MN
55112
Modifications to a controlled environment.
P950024/S042
8/30/12
CapSure Epicardial Pacing Lead Medtronic, Inc.
Mounds View, MN
55112
Modifications to a controlled environment.
P950029/S071
8/23/12
Reply SR and DR, Esprit SR and DR Sorin CRM
Plymouth, MN
55441
Addition of a cleaning step and new electrical test equipment.
P960009/S150
8/1/12
Activa Family of Implantable of Neurostimulators Medtronic Neuromodulation
Minneapolis, MN
55432
Requested a change to the final functional test.
P960009/S151
8/10/12
DBS Extensions and DBS Leads Medtronic Neuromodulation
Minneapolis, MN
55432
Addition of a duplicate EtO Sterilization System.
P960009/S153
8/22/12
Soletra, Kinetra, Activa SC. and Pocket Adaptors Medtronic Neuromodulation
Minneapolis, MN
55432
Addition of another supplier for the Inner Seal Silicone Component
117988-001.
P960040/S267
8/22/12
Teligen, Incepta, Energen and Punctua ICDs Boston Scientific Corporation
St. Paul, MN
55112
Add an Automatic Optical Inspection (AOI) system used to inspect component placed on the printed circuit board.
P960058/S097
8/24/12
HiResolution Bionic Ear Systems Advanced Bionics
Sylmar, CA
91342
Change in the biological indicator used in the firm’s Ethylene Oxide sterilization process.
P970004/S137
8/10/12
SNS Urinary Extensions and SNS Urinary Leads Medtronic Neuromodulation
Minneapolis, MN
55432
Addition of a duplicate EtO Sterilization System.
P970004/S139
8/22/12
InterStim Medtronic Neuromodulation
Minneapolis, MN
55432
Addition of another supplier for the Inner Seal Silicone Component
117988-001.
D970012/S092
8/2/12
AMS Ambicor Penile Prosthesis and AMS 700 Inflatable Penile Prosthesis American Medical Systems, Inc.
Minnetonka, MN
55343
Change in the label database server and a labeling software revision to the NiceLabel System.
P970020/S074
8/14/12
Multi-link 8 Coronary Stent System (CSS) Abbott Vascular
Temecula, CA
92591
Addition of a new test to inspect tubing used in the manufacturing of stents for the devices.
P970051/S092
8/24/12
Nucleus 24 Cochlear Implant System Cochlear Americas
Centennial, CO
80111
Implementation of a new cleaning system for the implant electronic assemblies for the C124RE(CA), C124RE(ST), and C1422 Nucleus Cochlear Implants.
P980007/S026
8/29/12
ARCHITECT FREE PSA Abbott Laboratories
Abbott Park, IL
60064
Change to the manufacturing material used to filter the common accessories.
P980016/S365
8/1/12
Maximo II, Maximo II DF4, Protecta, Protecta DF4, Protecta XT, Protecta XT DF4, Secura, Secura DF4, Virtuoso, Virtuoso II DR/VR, and EnTrust ICDs Medtronic, Inc.
Mounds View, MN
55112
Changes to the Radio Frequency Device Test application.
P980016/S367
8/10/12
Maximo II DF4 CRT-D, Maximo II DF4 ICD, Maximo II ICD, Secura DF4 ICD Secura ICD, Virtuoso II DR/VR ICD Medtronic, Inc.
Mounds View, MN
55112
Updates to the next generation hybrid tester software.
P980016/S368
8/14/12
Maximo II DF4 CRT-D, Maximo II DF4 ICD, Maximo II ICD, Secura
DF4 ICD, Secura ICD, and Virtuoso II DR/VR ICD
Medtronic, Inc.
Mounds View, MN
55112
Updates to the hybrid testing process.
P980016/S369
8/20/12
EnTrust lCD, Intrinsic lCD, Marquis DR lCD, Marquis VR ICD, Maximo DR lCD, Maximo II DR4 ICD, Maximo II lCD, Maximo VR lCD, Protecta DF4 lCD, Protecta lCD, Protecta XT DF4 ICD, Protecta XT lCD, Secura DF4 lCD, Secura ICD, Virtuso lCD, Virtuoso II DR/VR lCD Medtronic, Inc.
Mounds View, MN
55112
Manufacturing lines in a new extension of a controlled environment area.
P980016/S370
8/17/12
EnTrust ICD, Intrinsic ICD, Marquis DR ICD, Marquis VR ICD, Maximo DR ICD, Maximo II DF4 ICD, Maximo II ICD, Maximo VR ICD, Protecta DF4 ICD, Protecta ICD, Protecta XT DF4 ICD, Protecta XT ICD, Secura DF4 ICD, Secura ICD, Virtuoso ICD, Virtuoso II DR/VR ICD Medtronic, Inc.
Mounds View, MN
55112
New pressure test equipment used to verify hermeticity.
P980016/S371
8/22/12
Maximo II ICD, Protecta ICD, Protecta XT ICD, Secura ICD, and
Virtuoso II DR/VR ICD
Medtronic, Inc.
Mounds View, MN
55112
CMOS process flow changes at the supplier.
P980016/S372
8/27/12
Maximo II, Protecta, Protecta XT, Secura and Virtuoso II DR/VR ICDs Medtronic, Inc.
Mounds View, MN
55112
Update test software and hardware on the Teradyne Test Platform for M019 and M017 integrated circuits.
P980016/S373
8/30/12
EnTrust ICD, Intrinsic ICD, Marquis DR ICD, Marquis VR ICD. Maximo DR ICD, Maximo II ICD, Maximo VR ICD, Protecta ICD. Protecta XT ICD, Secura ICD, Virtuoso ICD and Virtuoso II DR/VR lCD Medtronic, Inc.
Mounds View, MN
55112
Modifications to a controlled environment.
P980016/S375
8/31/12
Maximo II, Secura and Virtuoso II DR/VR ICDs Medtronic, Inc.
Mounds View, MN
55112
Update test software for the CD Surge Tester.
P980022/S120
8/17/12
Paradigm REAL-Time System, Paradigm REAL-Time Revel System and Guardian REAL-Time System Medtronic MiniMed, Inc.
Northridge, CA
91325
Transfer of the sub-assembly manufacturing processes of the MiniLink Real-Time Transmitter (MMT-7703) from IntriCon Corporation in Arden Hills, Minnesota to an alternate manufacturing facility at IntriCon in Admirax, Singapore. The MiniLink Real-Time Transmitter is a component of the devices.
P980035/S278
8/10/12
Adapta, Versa, Sensia and Relia IPGs Medtronic, Inc.
Mounds View, MN
55112
Updates to the Proteus Device Test System software.
P980035/S279
8/6/12
Adapta, Adapta L, Adapta S, Sensia L, Sensia, Versa IPG, Sigma DR IPG, Sigma S IPG Medtronic, Inc.
Mounds View, MN
55112
Alternate suppliers of molded silicone components.
P980035/S281
8/20/12
Adapa, Adapta L, Adapta S, Sensia L, Sensia, Versa IPG, Advisa DR IPG, EnRyhthm IPG, Relia IPG Medtronic, Inc.
Mounds View, MN
55112
Manufacturing lines in a new extension of a controlled environment area.
P980035/S282
8/17/12
Adapta, Adapta L, Adapta S, Scnsia L, Sensia, Versa IPG, Advisa DR IPG, EnRhythm IPG, Relia IPG Medtronic, Inc.
Mounds View, MN
55112
New pressure test equipment used to verify hermeticity.
P980035/S283
8/22/12
Adapta, Adapta L, Adapta S, Sensia L, Sensia, Versa IPG, Advisa DR IPG, and Relia IPG Medtronic, Inc.
Mounds View, MN
55112
CMOS process flow changes at the supplier.
P980035/S284
8/27/12
Advisa DR IPG Medtronic, Inc.
Mounds View, MN
55112
Update test software and hardware on the Teradyne Test Platform for M019 and M017 integrated circuits.
P980035/S0285
8/30/12
Adapta, Adapta L, Adapta S, Sensia L, Sensia, Versa IPG, Advisa DR IPG, EnRhythm IPG, Relia IPG, Sigma DR IPG and
Sigma S IPG
Medtronic, Inc.
Mounds View, MN
55112
Modifications to a controlled environment.
P980049/S077
8/23/12
Paradym VR and DR, Paradym RF VR and DR Sorin CRM
Plymouth, MN
55441
Addition of a cleaning step and new electrical test equipment.
P980050/S075
8/30/12
Transvene Lead Medtronic, Inc.
Mounds View, MN
55112
Modifications to a controlled environment.
P990001/S106
8/20/12
Vitatron C20 SR IPG, Vitatron C60 DR IPG, Vitatron T20 SR IPG,
Vitatron T60 DR IPG
Medtronic, Inc.
Mounds View, MN
55112
Manufacturing lines in a new extension of a controlled environment area.
P990001/S107
8/17/12
Vitatron C20 SR IPG, Vitatron C60 DR IPG, Vitatron T20 SR IPG, VitatronT60 DR IPG Medtronic, Inc.
Mounds View, MN
55112
New pressure test equipment used to verify hermeticity.
P990001/S108
8/30/12
Vitatron C20 SR IPG, Vitatron C60 DR IPG, Vitatron T20 SR IPG and Vitatron T60 DR IPG Medtronic, Inc.
Mounds View, MN
55112
Modifications to a controlled environment.
P990064/S043
8/23/12
Mosaic Porcine Bioprosthesis Medtronic, Inc.
Santa Ana, CA
92705
Addition of an in-process tissue quality control test to measure muscle bar.
P990081/S013
8/9/12
PATHWAY HER2/NEU (4B5) Rabbit Monoclonal Primary Antibody Ventana Medical Systems, Inc.
Tucson, AZ
85755
Addition of a supplier of raw materials for the iView Detection kit, which is part
of the device.
P000053/S044
8/2/12
AMS 800 Urinary Control System American Medical Systems, Inc.
Minnetonka, MN
55343
Change in the label database server and a labeling software revision to the NiceLabel System.
P010012/S297
8/22/12
Cognis, Incepta, Energen and Punctua CRT-Ds Boston Scientific Corporation
St. Paul, MN
55112
Add an Automatic Optical Inspection (AOI) system used to inspect component placed on the printed circuit board.
P010014/S037
8/15/12
Oxford Meniscal Unicompartmental Knee System Biomet Manufacturing Corporation
Warsaw, IN
46582
Changes to the device sterile packaging.
P010015/S167
8/20/12
Consulta CRT-P and Syncra CRT-P Medtronic, Inc.
Mounds View, MN
55112
Manufacturing lines in a new extension of a controlled environment area.
P010015/S168
8/17/12
Consulta CRT-P, Syncra CRT-P Medtronic, Inc.
Mounds View, MN
55112
New pressure test equipment used to verify hermeticity.
P010015/S169
8/22/12
Consulta CRT-P, Syncra CRT-P Medtronic, Inc.
Mounds View, MN
55112
CMOS process flow changes at the supplier.
P010015/S170
8/27/12
Consulta and Syncra CRT-Ps Medtronic, Inc.
Mounds View, MN
55112
Update test software and hardware on the Teradyne Test Platform for M019 and M017 integrated circuits.
P010015/S171
8/30/12
Attain Bipolar OTW Lead, Consulta CRT-P, Left Ventricular Pacing Lead, and Syncra CRT-P Medtronic, Inc.
Mounds View, MN
55112
Modifications to a controlled environment.
P010019/S033
8/9/12
Lotrafilcon Soft Contact Lenses for Extended Wear CIBA Vision Corporation
Duluth, GA
30097
Improved measurement on the particle size of a component.
P010020/S025
8/2/12
Acticon Neosphincter American Medical Systems, Inc.
Minnetonka, MN
55343
Change in the label database server and a labeling software revision to the NiceLabel System.
P010031/S317
8/1/12
Concerto, Concerto II, Consulta, Consulta DF4, Maximo II, Maximo II DF4, Protecta, Protecta DF4, Protecta XT, and Protecta XT DF4 CRT-Ds Medtronic, Inc.
Mounds View, MN
55112
Changes to the Radio Frequency Device Test application.
P010031/S320
8/10/12
Concerto II CRT-D, Consulta DF4 ICD, Consulta ICD, Maximo II CRT-D, Maximo II DF4 CRT-D Medtronic, Inc.
Mounds View, MN
55112
Updates to the next generation hybrid tester software.
P010031/S321
8/14/12
Concerto II CRT-D, Consulta DF4 ICD, Consulta ICD, Maximo II CRT-D,
and Maximo II DF4 CRT-D
Medtronic, Inc.
Mounds View, MN
55112
Updates to the hybrid testing process.
P010031/S322
8/20/12
Concerto ICD, Concerto II CRT-D, Consulta lCD, lnSync III Marquis lCD, lnSync Maximo lCD, Maximo II CRT-D, Maximo II DF4 CRT-D, Protecta CRT-D, Protecta DF4 CRT-D, Protecta XT CRT-D, and Protecta XT DF4 CRT-D Medtronic, Inc.
Mounds View, MN
55112
Manufacturing lines in a new extension of a controlled environment area.
P010031/S323
8/17/12
Concerto ICD, Concerto II CRT-D, Consulta DF4 ICD, Consulta, InSync III Marquis ICD, InSync Maximo ICD, Maximo II CRT-D, Maximo II DF4 CRT-D, Protecta CRT-D, Protecta DF4 CRT-D, Protecta XT CRT-D, Protecta XT DF4 CRT-D Medtronic, Inc.
Mounds View, MN
55112
New pressure test equipment used to verify hermeticity.
P010031/S324
8/22/12
Concerto II CRT-D, Consulta DF4 1CD, Consults ICD, Maximo II CRT-D. Protecta CRT-D, and Protecta XT CRT-D Medtronic, Inc.
Mounds View, MN
55112
CMOS process flow changes at the supplier.
P010031/S325
8/27/12
Consulta and Consulta DF4 ICDs and Concerto II, Maximo II, Protecta and Protecta XT CRT-Ds Medtronic, Inc.
Mounds View, MN
55112
Update test software and hardware on the Teradyne Test Platform for M019 and M017 integrated circuits.
P010031/S326
8/30/12
Concerto ICD, Concerto II CRT-D, Consulta DF4 ICD, Consulta ICD,
InSync III Marquis ICD, InSync Maximo ICD, Maximo II CRT-D,
Protecta CRT-D, and Protecta XT CRT-D
Medtronic, Inc.
Mounds View, MN
55112
Modifications to a controlled environment.
P010031/S328
8/31/12
Consulta, Consulta DF4 ICDs, Concerto II and Maximo II CRT-Ds Medtronic, Inc.
Mounds View, MN
55112
Update test software for the CD Surge Tester.
P010032/S056
8/1/12
EonMini IPG System St. Jude Medical
Plano, TX
75024
Change to the in-process and final inspection impedance test.
P010032/S060
8/10/12
Eon, EonC™ & Econ Mini™ Neurostimulation IPG Systems St. Jude Medical
Plano, TX
75024
Software revision to an in-process inspection step.
P010032/S062
8/31/12
Penta™ Lead Series St. Jude Medical
Plano, TX
75024
Change the in- process dimensional inspection for the devices.
P020009/S090
8/31/12
Express 2 Coronary Stent Systems Boston Scientific Corporation
Maple Grove, MN
55311
Removal of in- process monitoring for seal burst testing.
P020047/S049
8/14/12
VISION and MINI-VISION Coronary Stent System (CSS) Abbott Vascular
Temecula, CA
92591
Addition of a new test to inspect tubing used in the manufacturing of stents for the devices.
P020047/S050
8/24/12
MULTI-LINK 8 Coronary Stent System Abbott Vascular
Temecular, CA
92591
Irradiation equipment change for the manufacturing of the devices.
P030017/S139
8/15/12
Precision® Spinal Cord Stimulator System Boston Scientific Neuromodulation
Valencia, CA
91355
Allow cable ablation to be processed in-house.
P030036/S045
8/6/12
SelectSecure Lead Medtronic, Inc.
Mounds View, MN
55112
Alternate suppliers of molded silicone components.
P030036/S046
8/30/12
Anchoring Sleeve Kit and SelectSecure Lead Medtronic, Inc.
Mounds View, MN
55112
Modifications to a controlled environment.
P030052/S009
8/10/12
UroVysion Bladder Cancer Kit Abbott Molecular, Inc.
Des Plaines, IL
60018
Eliminate a second clone identity testing procedure at the fermentation stage for LSI 9p21, qualify the GENEPREP instrument, qualify the overhead mixing system and validation of mixing process in the manufacture of hybridization buffer, implement the optical density reading as an additional in process quality control, validate an existing mixing process for the UroVysion bulk solution, and transfer an existing in-process testing of labeled DNA.
P030054/S225
8/8/12
Merlin Patient Care System Accessories St. Jude Medical
Sylmar, CA
91342
Alternate supplier for ECG Cables.
P030054/S228
8/30/12
Epic, Atlas, Promote, Unify, Unify Assura, Unify Quadra, Quadra Assura Family of CRT-D Devices St. Jude Medical
Sylmar, CA
91342
Addition of an alternate supplier for a seal component.
P040016/S094
8/31/12
VeriFLEX (Libertè) Bare-Metal Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Removal of in- process monitoring for seal burst testing.
P040024/S061
8/10/12
Restylane Injectable Gel Medicis Pharmaceutical Corporation
Scottsdale, AZ
85256
Transfer of laboratory testing equipment to the newly constructed quality control laboratory testing site within the
Q-Med facility.
P050012/S048
8/3/12
SEVEN® and SEVEN® PLUS Continuous Glucose Monitoring Systems Dexcom, Inc.
San Diego, CA
92121
Addition of an alternative component supplier. Actimed, for the pushrod and cannula components of the Sensor applicator of the device.
P050039/S010
8/24/12
Novation Ceramic Articulation Hip System Exactech, Inc.
Gainesville, FL
32653
Changes to the process for use of the burst test fixture, which is used to evaluate the seal strength of the packaging.
P050042/S018
8/30/12
ARCHITECT Anti-HCV Abbott Laboratories
Abbott Park, IL
60064
Change to the manufacturing material used to filter the common accessories.
P050046/S015
8/27/12
Acuity Steerable Implantable Leads Boston Scientific
St. Paul, MN
55112
Additional supplier for a lead component.
P050051/S015
8/30/12
ARCHITECT AUSAB Abbott Laboratories
Abbott Park, IL
60064
Change to the manufacturing material used to filter the common accessories.
P060006/S032
8/31/12
Express SD Monorail Premounted Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Removal of in- process monitoring for seal burst testing.
P060007/S019
8/30/12
ARCHITECT HBsAg and HBsAg Confirmatory Abbott Laboratories
Abbott Park, IL
60064
Change to the manufacturing material used to filter the common accessories.
P060027/S045
8/23/12
Paradym CRT-D, Paradym RF CRT-D Sorin CRM
Plymouth, MN
55441
Addition of a cleaning step and new electrical test equipment.
P060033/S071
8/31/12
Endeavor Sprint Zotarolimus-Eluting Coronary Stent Systems Medtronic Vascular
Santa Rosa, CA
95403
Manufacturing equipment change to the Initial Crimp Stent process.
P060035/S014
8/30/12
ARCHITECT CORE-M Abbott Laboratories
Abbott Park, IL
60064
Change to the manufacturing material used to filter the common accessories.
P060037/S018
8/10/12
NexGen® LPS Flex Mobile and LPS-Mobile Bearing Knee System Zimmer, Inc.
Warsaw, IN
46581
Change in package heat sealing process parameters for the inner pouch.
P060039/S035
8/30/12
Attain StarFix Lead Medtronic, Inc.
Mounds View, MN
55112
Modifications to a controlled environment.
P070015/S097
8/14/12
XIENCE V and Nano Everolimus Eluting Coronary Stem System
(EECSS)
Abbott Vascular
Temecula, CA
92591
Addition of a new test to inspect tubing used in the manufacturing of stents for the devices.
P070015/S098
8/27/12
XIENCE V and Nano Everolimus Eluting Coronary Stem System
(EECSS)
Abbott Vascular
Temecula, CA
92591
Alternate storage conditions for the long-term of the everolimus drug substance.
P080006/S042
8/30/12
Attain Ability Leads Medtronic, Inc.
Mounds View, MN
55112
Modifications to a controlled environment.
P080023/S015
8/30/12
ARCHITECT CORE Abbott Laboratories
Abbott Park, IL
60064
Change to the manufacturing material used to filter the common accessories.
P080025/S034
8/10/12
SNS Bowel Extensions and SNS Bowel Leads Medtronic Neuromodulation
Minneapolis, MN
55432
Addition of a duplicate EtO Sterilization System.
P080025/S036
8/22/12
InterStim Medtronic Neuromodulation
Minneapolis, MN
55432
Addition of another supplier for the Inner Seal Silicone Component
117988-001.
P090003/S013
8/3/12
Express LD Iliac Premounted Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Change to the aeration cycle time for the 40C ethylene oxide sterilization cycle.
P090013/S066
8/14/12
CapSureFix MRI Medtronic, Inc.
Mounds View, MN
55112
Additional laser welder to perform the laser weld process of the connector pin to the coil.
P0900013/S067
8/20/12
Revo MRI IPG Medtronic, Inc.
Mounds View, MN
55112
Manufacturing lines in a new extension of a controlled environment area.
P090013/S068
8/17/12
Revo MRI IPG Medtronic, Inc.
Mounds View, MN
55112
New pressure test equipment used to verify hermeticity.
P090013/S069
8/30/12
CapSureFix MRI Lead and Revo MRI IPG Medtronic, Inc.
Mounds View, MN
55112
Modifications to a controlled environment.
P100013/S005
8/14/12
EXOSEAL Vascular Closure Device Cordis Corporation
Bridgewater, NJ
08807
Implementation changes to the pouch sealing process.
P100023/S050
8/14/12
ION (TAXUS Element) Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Changes to the inspection mandrel verification process.
P100023/S051
8/22/12
ION Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Pre-sterilization equipment change to the ethylene oxide sterilization process for the device.
P100041/S013
8/9/12
SAPIEN Transcatheter Heart Valve Edwards Lifesciences, LLC
Irvine, CA
92614
Upgrade to braiding equipment and removal of surfactant for a manufacturing process.
P100044/S002
8/10/12
Propel Sinus Implant Intersect ENT
Palo Alto, CA
94303
Modification to a quality control test used on an incoming component.
P110001/S008
8/14/12
Herculink Elite RX Stent System Abbott Vascular
Temecula, CA
92591
Addition of a new test to inspect tubing used in the manufacturing of stents for the devices.
P110010/S025
8/14/12
Promus Element Plus Everolimus-Eluting Chromium Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Changes to the inspection mandrel verification process.
P110019/S026
8/14/12
XIENCE PRIME and PRIME LL Everolimus Eluting Coronary Stent
System (EECSS)
Abbott Vascular
Temecula, CA
92591
Addition of a new test to inspect tubing used in the manufacturing of stents for the devices.
P110019/S027
8/24/12
XIENCE PRIME Coronary Stent System Abbott Vascular
Temecula, CA
92591
Irradiation equipment change for the manufacturing of the devices.
P110019/S028
8/27/12
XIENCE Prime and XIENCE Prime LL Everolimus-Eluting Coronary Stent System Abbott Vascular
Temecula, CA
92591
Alternate storage conditions for the long-term storage of the everolimus drug substance.
P110029/S003
8/30/12
ARCHITECT HBsAg Qualitative and HBsAg Qualitative Confirmatory Abbott Laboratories
Abbott Park, IL
60064
Change to the manufacturing material used to filter the common accessories.

Summary of PMA Originals & Supplements Approved
Originals: 0
Supplements: 71

Summary of PMA Originals Under Review
Total Under Review: 65
Total Active: 34
Total On Hold: 31
Number Greater Than 180 Days: 1

Summary of PMA Supplements Under Review
Total Under Review: 601
Total Active: 449
Total On Hold: 152
Number Greater Than 180 Days: 5

Summary of All PMA Submissions Received
Originals: 2
Supplements: 88

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 71
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 157.3
FDA Time: 122.2 Days MFR Time: 35.1 Days

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