Medical Devices

January 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
P130004
1/8/14
ReSure® SealantOcular Therapeutix, Inc.
Bedford, MA
01730
Approval for the ReSure® Sealant. This device is indicated for intraoperative management of clear corneal incisions (up to 3.5mm) with a demonstrated wound leak for which a temporary dry surface can be achieved, in order to prevent postoperative fluid egress from such incisions following cataract surgery with intraocular lens (IOL) placement in adults.
P130021
1/17/14
Medtronic CoreValve™ System (MCS): Transcatheter Aortic Valve (TAV), Models MCS-P4-23-AOA (23 mm; CoreValve™ Evolut™), MCS-P3-26-AOA (26 mm), MCS-P3-29-AOA (29 mm), and MCS-P3-31-AOA (31 mm); Delivery Catheter System (DCS), Models DCS-C4-18FR and DCS-C4-18FR-23; and Compression Loading System (CLS), Model CLS-3000-18FRMedtronic CoreValve, LLC
Santa Rosa, CA 95403
Approval for the Medtronic CoreValve™ System. This device is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis (aortic valve area ≤ 0.8 cm2, a mean aortic valve gradient of > 40 mmHg, or a peak aortic-jet velocity of > 4.0 m/s) and with native aortic annulus diameters between 18 and 29 mm who are judged by a heart team, including a cardiac surgeon, to be at extreme risk or inoperable for open surgical therapy (predicted risk of operative mortality and/or serious irreversible morbidity ≥50% at 30 days).

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
P830055/S138
1/22/14
135-Day
LCS Total Knee SystemDePuy Orthopaedics, Inc.
Warsaw, IN 46581
Approval for changes to device identifiers and part identification verification processes.
P860004/S184
1/8/14
180-Day
Clinician Programmer, Telemetry Head, Synchromed III Implantable Programmable Infusion Pump, Synchromed II Implantable Programmable Infusion PumpMedtronic, Inc.
Minneapolis, MN
55432
Approval for the release of a Clinical Summary for Synchromed II Clinical Accuracy.
P860057/S116
1/24/14
180-Day
Carpentier-Edwards Perimount Magna Mitral Pericardial BioprosthesisEdwards Lifesciences, LLC.
Irvine, CA 92614
Approval of the post-approval study protocol.
P890003/S290
1/22/14
Real-Time
CapSure VDD-2 LeadsMedtronic, Inc.
Mounds View, MN
55112
Approval for use of new silicone insulation tubing materials.
P890055/S053
1/22/14
Special
MedStream™ Programmable Infusion System; MedStream™ Control Unit; MedStream™ Refill Kit; MedStream™ Bolus Kit; CODMAN® Operating Room Prep KitCodman & Shurtleff, Incorporated
325 Paramount Drive,
Raynham, MA 02767
Approval for addition of a 100% inspection to verify the Use by Date on the labels of the MedStream Implantable Infusion Pump System.
P910001/S065
1/14/14
180-Day
CVX-300 4.0 and CVX-300 4.0P Excimer Laser SystemSpectranetics Corporation
Colorado Springs, CO
80921
Approval for new circuitry and optical components to improve control of the regulated energy output of the CVX-300 laser generator.
P920015/S122
1/22/14
Real-Time
Lead AdaptorMedtronic, Inc.
Mounds View, MN
55112
Approval for use of new silicone insulation tubing materials.
P950005/S047
1/22/14
Real-Time
Celsius FLTR Bi-directional CatheterBiosense Webster, Inc.
Diamond Bar, CA
91765
Approval for manufacturing and design changes to the catheter tip.
P960043/S083
1/16/14
135-Day
Perclose ProGlide®/Perclose AT® Suture Mediated Closure Systems and Snared Knot PusherAbbott Vascular Inc.
Santa Clara, CA 95054
Approval for the use of an internal facility as an additional supplier of three extruded components.
P970029/S025
1/28/14
180-Day
Holmium Laser System Fiber Optic Delivery System HandpieceCardiogenesis Corporation
Kennesaw, GA 30144
Approval of the post-approval study protocol.
P970051/S094
1/21/14
180-Day
Nucleus Cochlear Implant System: Cochlear Integrity Test SystemCochlear Americas
Centenial, CO 80111
Approval for the Cochlear Integrity Test System (CITS).
P980022/S133
1/15/14
180-Day
Paradigm Real-Time System, Paradigm Real-Time Revel SystemMedtronic MiniMed
Northridge, CA 91325
Approval for the reduction of keypad button (dome) sizes, new keypad overlay supplier (Bergquist), and keypad/ overlay/ case assembly process for the Paradigm REAL-Time Insulin Pumps (Models: MMT-522, MMT-522K, MMT-722, MMT-722K and Paradigm REAL-Time Revel Insulin Pumps (Models: MMT-523, MMT-523K, MMT-723, and MMT-723K) that are components of the Paradigm REAL-Time and Paradigm REAL-Time Revel Systems, respectively.
P980023/S054
1/17/14
135-Day
Linox, Linoxsmart, Vigila, and Volta ICD leadsBiotronik
Lake Oswega, OR
97035
Approval for an alternate supplier for shock coils used in the subject leads.
P000025/S072
1/10/14
135-Day
COMBI 40+ Cochlear Implant System (Mi1000 MED-EL CONCERT and SONATATI100)MED-EL Elektro-Medizinische Geräte GmbH
Innsbruck – Fürstenweg, Austria
77a
Approval for an alternate welding process.
P010005/S007
1/29/14
180-Day
ProstaLund CoreTherm® Accessories for Small Prostates CoreTherm Catheter Short (CA804120); Microwave Antenna Short (AN806101); and lntraprostatic Temperature Probe Short (IP807101)ProstaLund Operations AB
Uppsala, Sweden
SE-751 06
Approval for modification of the indications for use and associated modifications to the catheter, antenna, and temperature probe for patients with prostates smaller than currently indicated. The device, as modified, will be marketed under the trade name CoreTherm® Accessories for Small Prostates and is indicated for use together with ProstaLund CoreTherm® /SE in patients with glands size 20-50g and with a prostate length ≥25 mm.
P010068/S036
1/22/14
Real-Time
Celsius FLTR Uni-directional CatheterBiosense Webster, Inc.
Diamond Bar, CA
91765
Approval for manufacturing and design changes to the catheter tip.
P030027/S007
1/3/14
135-Day
Ceramic TRANSCEND® Articulation SystemWright Medical Technology, Inc.
Arlington, TN 38002
Approval for changing the incoming inspection process of components from the supplier.
P030052/S012
1/24/14
180-Day
UroVysion Bladder Cancer KitAbbott Molecular, Inc.
Des Plaines, IL 60018
Approval for a manufacturing site located at Leica Biosystems in Solon Mills, Illinois.
P040002/S044
1/24/14
Real-Time
AFX Endovascular AAA System with Vela Proximal Endograft Delivery SystemEndologix, Inc.
Irvine, CA 92618
Approval for dimensional modification of the inner core of the AFX Vela Proximal Endograft Delivery System.
P040045/S041
1/16/14
180-Day
VISTAKON (senofilcon A) Brand Contact LensesJohnson & Johnson Vision Care, Inc.
Jacksonville, FL 32256
Approval for a change in the viscosity specification from 120-170 cps to 100-170 cps for the reactive monomer mix.
P050007/S031
1/16/14
135-Day
StarClose SE® Vascular Closure SystemAbbott Vascular Inc.
Santa Clara, CA 95054
Approval for the use of an internal facility as an additional supplier of three extruded components.
P050023/S073
1/17/14
Real-Time
Lumax 300 and 500 Families of ICD’s and CRT-D’sBiotronik, Inc.
Lake Oswego, OR
97035
Approval for a modification of the land pad geometry for the high voltage diodes on the substrate.
P050044/S027
1/27/14
135-Day
Vitagel RT Surgical Hemostat (Vitagel RT3 Surgical Hemostat)Stryker Orthobiologics
Malvern, PA 19355
Approval of the transfer of sterility testing of Vitagel RT3 filled syringes inhouse.
P060008/S107
1/21/14
180-Day
Drug-Eluting Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Approval of the post-approval study protocol.
P060029/S005
1/17/14
180-Day
Ethicon OMNEX Surgical SealantEthicon, Inc.
Somerville, NJ 08876
Approval for a manufacturing site located at Ethicon, Inc., in Cornelia, Georgia.
P070014/S041
1/22/14
Special
LifeStent Vascular Stent SystemC.R. Bard, Inc.
Tempe, AZ 85281
Approval for an additional labeling verification inspection method for the device packaging.
P080007/S019
1/22/14
Special
E-Luminexx Vascular Stent SystemC.R. Bard, Inc.
Tempe, AZ 85281
Approval for an additional labeling verification inspection method for the device packaging.
P090006/S009
1/22/14
135-Day
Complete SE Vascular Stent SystemMedtronic Vascular
Santa Rosa, CA 95403
Approval for multiple stent processing changes for the Complete SE Vascular Stent System.
P100009/S002
1/28/14
180-Day
Mitral Valve Repair and Clip Delivery Systems (MitraClip®)Abbott Vascular, Inc.
Menlo Park, CA 94025
Approval of the post-approval study protocol.
P100014/S009
1/14/14
180-Day
SolestaSalix Pharmaceuticals, Inc.
Raleigh, NC
27615
Approval for the revision of the prescribing information to include 24 and 26 month data.
P100021/S027
1/24/14
180-Day
Endurant Stent Graft SystemMedtronic Vascular
Santa Rosa, CA 95403
Approval of the post-approval study protocol.
P100040/S012
1/22/14
Panel-Track
Valiant Thoracic Stent Graft with Captivia Delivery SystemMedtronic Vascular
Santa Rosa, CA 95403
Approval for the Valiant Thoracic Stent Graft with Captivia Delivery System (Valiant Captivia). This device is indicated for the endovascular repair of all lesions of the descending thoracic aorta (DTA) in patients having the appropriate anatomy including: 1) iliac or femoral artery access vessel morphology that is compatible with vascular access techniques, devices or accessories; nonaneurysmal aortic diameter in the range of 18 mm to 42 mm (fusiform and saccular aneurysms/ penetrating ulcers), or 18 mm to 44 mm (blunt traumatic aortic injuries), or 20 mm to 44 mm (dissections); and nonaneurysmal aortic proximal and distal neck lengths ≥ 20 (fusiform and saccular aneurysms/ penetrating ulcers), landing zone ≥20 mm proximal to the primary entry tear (blunt traumatic aortic injuries, dissections). The proximal extent of the landing zone must not be dissected.
P100040/S013
1/7/14
Real-Time
Valiant Thoracic Stent Graft System with Captivia Delivery SystemMedtronic Vascular
Santa Rosa, CA 95403
Approval for a product line extension consisting of the addition of 11 Valiant Freeflo Tapered Stent Grafts. The device, as modified, will be marketed under the trade name Valiant Thoracic Stent Graft System with Captivia Delivery System and is indicated for the endovascular repair of isolated lesions (excluding dissections) of the descending thoracic aorta in patients having appropriate anatomy, including: iliac or femoral artery access vessel morphology that is compatible with vascular access techniques, devices, or accessories; nonaneurysmal aortic diameter in the range of 18 to 42 mm (fusiform and saccular aneurysms/ penetrating ulcers) or 18 mm to 44 mm (blunt traumatic aortic injuries); and nonaneurysmal aortic proximal and distal neck lengths ≥ 20 mm.
P100041/S037
1/31/14
135-Day
SAPIEN™ Transcatheter Heat Valve and Transfemoral AccessoriesEdwards Lifesciences, LLC
Irvine, CA 92614
Approval for a change in material to the mandrels used as manufacturing aids for the delivery system.
P100044/S012
1/31/14
180-Day
Propel Mini Sinus ImplantIntersect ENT
Menlo Park, CA 94025
Approval to revise the release rate specification.
P100044/S013
1/9/14
Real-Time
Propel® Mini Sinus ImplantIntersect ENT
Menlo Park, CA 94025
Approval for a design modification to the Delivery System Accessory component of the previously approved Propel Mini Sinus Implant.
P110012/S004
1/24/14
180-Day
Vysis ALK Break Apart FISH Probe KitAbbott Molecular, Inc.
Des Plaines, IL 60018
Approval for a manufacturing site located at Leica Biosystems in Solon Mills, Illinois.
P110013/S028
1/30/14
180-Day
Resolute Integrity Zotarolimus-Eluting Coronary Stent SystemMedtronic, Inc.
Santa Rosa, CA 95403
Approval for modifications to the Resolute Integrity Zotarolimus-Eluting Coronary Stent System Instructions for Use (IFU) to include updated clinical information.
P110019/S055
1/14/14
Real-Time
XIENCE Xpedition Everolimus Eluting Coronary Stent SystemAbbott Vascular
Temecula, CA 92589
Approval for a labeling change for the XIENCE Xpedition , XIENCE Xpedition SV, and the XIENCE Xpedition LL Everolimus Eluting Coronary Stent System for the OTW platform. This labeling change requested a shelf life extension from 12 to 24 months.
P110019/S058
1/7/14
180-Day
XIENCE Xpedition Stent SystemAbbott Vascular
Temecula, CA 92589
Approval for a manufacturing site located in North Brunswick, New Jersey.
P110021/S024
1/31/14
SAPIEN™ Transcatheter Heart Valve and Transfemoral and Transapical AccessoriesEdwards Lifesciences, LLC
Irvine, CA 92614
Approval for a change in material to the mandrels used as manufacturing aids for the delivery system.
P110028/S011
1/16/14
135-Day
Absolute Pro® Vascular Self-Expanding Stent SystemAbbott Vascular
Temecula, CA 92591
Approval for a change to the stent sub-assembly cleaning process that occurs prior to the electropolish process.
P110042/S020
1/31/14
180-Day
Subcutaneous Implantable Defibrillator S-ICD SystemCameron Health, Inc.
San Clemente, CA
92673
Approval for a new battery supplier for the SQ-RX Model 1010 Implantable Pulse Generator.

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

APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
P800002/S020
1/14/14
Avitene Microfibrillar Collagen Hemostat ProductDavol, Inc.
Warwick, RI
02886
Add a new supplier for the blister tray used for the Avitene Microfibrillar Collagen Hemostat-Endo Avitene product.
P810006/S050
1/17/14
Collastat Absorbable Collagen Hemostatic SpongeIntegra LifeSciences Corporation
Plainsboro, NJ
08536
Change to introduce an alternate test method for bacterial endotoxin in collagen products.
P830061/S102
1/8/14
CAPSURE LeadMedtronic, Inc.
Mounds View, MN
55112
Use of SPACE Software Release 6.0 (Build 7), a statistical process control (SPC) software.
P820003/S126
1/16/14
Single and Dual Temporary PacemakersMedtronic, Inc.
Mounds View, MN
55112
Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products.
P830061/S104
1/16/14
CapSure Sense, CapSure SP, CapSure SP Novus, Vitatron Crystalline, Vitatron Excellence PS+ LeadsMedtronic, Inc.
Mounds View, MN
55112
Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products.
P830061/S105
1/16/14
CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead, Vitatron Excellence PS+ LeadMedtronic CRDM
Mounds View MN
55112
Use of the Incoming Inspection (Receiving Batch on Purchase order) work flow with SAP Quality Management (QM) Module.
P840001/S259
1/22/14
SCS Accessories; SCS Extensions; Hinged 2x4 Surgical Lead; Vectris SureScan 1x8 Leads; Pisces Leads; Resume Leads; Lead Revision Kits; Specify Leads; Trialing System Screening Cable; Vectris 1x8 trialing LeadsMedtronic Neuromodulation
Minneapolis, MN
55432
Manufacturing change associated with incoming inspection activities.
P840062/S037
1/17/14
CollaCote and CollaTape Absorbable Collagen Wound Dressings for Dental SurgeryIntegra LifeSciences Corporation
Plainsboro, NJ
08536
Change to introduce an alternate test method for bacterial endotoxin in collagen products.
P850010/S049
1/17/14
Helistat Absorbable Collagen Hemostatic AgentsIntegra LifeSciences Corporation
Plainsboro, NJ
08536
Change to introduce an alternate test method for bacterial endotoxin in collagen products.
P850089/S104
1/16/14
CapSure SP Novus, CapSure SP Z, CapSure Z Novus, Vitatron impulse II LeadsMedtronic, Inc.
Mounds View, MN
55112
Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products.
P850089/S105
1/16/14
CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II LeadMedtronic CRDM
Mounds View MN
55112
Use of the Incoming Inspection (Receiving Batch on Purchase order) work flow with SAP Quality Management (QM) Module.
P860057/S117
1/23/14
Carpentier-Edwards PERIMOUNT Pericardial Aortic and Mitral BioprosthesisEdwards Lifesciences, LLC
Irvine, CA
92614
Change in the polyester cloth manufacturing aid.
P870056/S064
1/23/14
Carpentier-Edwards Porcine Aortic and Mitral BioprosthesisEdwards Lifesciences, LLC
Irvine, CA
92614
Change in the polyester cloth manufacturing aid.
P870077/S058
1/23/14
Carpentier-Edwards Duraflex Low Pressure Mitral Bioprosthesis with Extended Suture Ring; Carpentier-Edwards Duraflex Low Pressure Porcine Mitral BioprosthesisEdwards Lifesciences, LLC
Irvine, CA
92614
Change in the polyester cloth manufacturing aid.
P890003/S294
1/9/14
MyCareLink Patient Monitor, MyCareLink Reader FRUMedtronic, Inc.
Mounds View, MN
55112
Process change for the MyCareLink Monitor Solder Process.
P890003/S298
1/16/14
CapSure LeadMedtronic, Inc.
Mounds View, MN
55112
Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products.
P890003/S300
1/16/14
MyCareLink Patient Monitor and Reader FRUMedtronic CRDM
Mounds View, MN
55112
Change in the test equipment/test method used in the quality control inspection process of the printed circuit board assemblies used in the MyCareLink Patient Monitor.
P890003/S301
1/16/14
CapSure LeadMedtronic CRDM
Mounds View MN
55112
Use of the Incoming Inspection (Receiving Batch on Purchase order) work flow with SAP Quality Management (QM) Module.
P890055/S052
1/15/14
MedStream Programmable Infusion SystemCodman & Shurtleff, Inc.
Raynham, MA 02767
New steam sterilizer.
P900056/S130
1/30/14
Rotablator Rotational Atherectomy SystemBoston Scientific Corporation
Maple Grove, MN
55311
Change to the long drive laser welder equipment used in the RotaLink long drive sub-assembly line.
P900061/S126
1/16/14
Epicardial Patch LeadMedtronic, Inc.
Mounds View, MN
55112
Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products.
P910001/S069
1/14/14
ELCA Coronary Atherectomy CathetersSpectranetics Corporation
Colorado Springs, CO
80921
Modifications to reduce the frequency of sterile barrier strength testing and a modification to the process of seal strength monitoring.
P920015/S127
1/16/14
Sprint Quattro, Transvene CS/SVC LeadsMedtronic, Inc.
Mounds View, MN
55112
Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products.
P920015/S128
1/16/14
Sprint Quattro Lead, HV Splitter/Adaptor KitMedtronic CRDM
Mounds View MN
55112
Use of the Incoming Inspection (Receiving Batch on Purchase order) work flow with SAP Quality Management (QM) Module.
P930014/S070
1/9/14
AcrySof Intraocular LensAlcon Research, Ltd.
Fort Worth, TX 76134
Use of a new aberrometer.
P930014/S071
1/13/14
AcrySof Monofocal Posterior Intraocular LensesAlcon Research, Ltd.
Fort Worth, TX 76134
Reduce frequency of a manufacturing inspection from a 100% inspection rate to a sample-based inspection plan for devices within a lot.
P930029/S040
1/16/14
RF Marinr MC (7fr), RF Marinr (5fr), RF Contactr, RF Conductr, Rf, Enhancr IIMedtronic, Inc.
Mounds View, MN
55112
Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products.
P930039/S098
1/8/14
CAPSUREFIX Novus LeadMedtronic, Inc.
Mounds View, MN
55112
Use of SPACE Software Release 6.0 (Build 7), a statistical process control (SPC) software.
P930039/S101
1/16/14
CapSure Fix, CapSureFix Novus, SureFix, Vitatron Crystalline LeadsMedtronic, Inc.
Mounds View, MN
55112
Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products.
P930039/S102
1/16/14
CapSureFix Novus Lead, Vitatron Crystalline LeadMedtronic CRDM
Mounds View MN
55112
Use of the Incoming Inspection (Receiving Batch on Purchase order) work flow with SAP Quality Management (QM) Module.
P950005/S049
1/24/14
Celsius, Celsius RMT, EZ Steer Non-Temp sensing Ablation CathetersBiosense Webster, Inc.
Diamond Bar, CA
91765
Change in the sterilization release method for Biosense Webster catheters and cables.
P950024/S056
1/16/14
CapSure Epicardial Pacing LeadMedtronic, Inc.
Mounds View, MN
55112
Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products.
P950024/S057
1/16/14
CapSure Epicardial Pacing LeadMedtronic CRDM
Mounds View, MN
55112
Use of the Incoming Inspection (Receiving Batch on Purchase order) work flow with SAP Quality Management (QM) Module.
P950037/S133
1/6/14
Selox ST 53, Selox ST 60, Selox JT 45,Selox JT 53, Setrox S 45, Setrox S 53, Setrox S 60, Dextrus 4135, Dextrus 4136, Detrus 4137 Pacing LeadsBiotronik, Inc.
Lake Oswego, OR
97035
Two additional injection molding tools used to manufacture the silicone sleeves of the pacemaker leads.
P950039/S027
1/29/14
ThinPrep Processor 2000/3000Hologic, Inc.
Marlborough, MA
01752
Addition of a specification on minimum cell transfer requirements for the ThinPrep Microscope Slides.
P960009/S187
1/22/14
DBS Accessories; DBS Extensions; DBS Leads; DBS Screening SystemsMedtronic Neuromodulation
Minneapolis, MN
55432
Manufacturing change associated with incoming inspection activities.
P960042/S047
1/14/14
Spectranetics Laser Sheaths SLSSpectranetics Corporation
Colorado Springs, CO
80921
Modifications to reduce the frequency of sterile barrier strength testing and a modification to the process of seal strength monitoring.
P960043/S085
1/29/14
Perclose Proglide® and Perclose AT® Suture Mediated Closure SystemsAbbott Vascular Inc.
Santa Clara, CA 95054
Change to the joint tensile testing process.
P960043/S086
1/30/14
Perclose ProGlide Suture Mediated Closure Device and Perclose AT 6F Suture Mediated Closure SystemAbbott Vascular Inc.
Santa Clara, CA 95054
Additional testing apparatus and procedure be included in the functional testing performed on the Gated Suture Trimmer.
P960058/S105
1/8/14
HiResolution Bionic Ear SystemAdvanced Bionics
Sylmar, CA
91342
Use of a new sterilization cycle.
P970003/S167
1/2/14
Cyberonics VNS Therapy SystemCyberonics, Inc.
Houston, TX
77058
Replace the capacitor used in the assembly of the printed circuit boards for the Programming Wand.
P970004/S166
1/22/14
SNS Urinary Extensions; SNS Urinary LeadsMedtronic Neuromodulation
Minneapolis, MN
55432
Manufacturing change associated with incoming inspection activities.
P970012/S094
1/16/14
Application Software, Remote AssistantMedtronic, Inc.
Mounds View, MN
55112
Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products.
N970012/S098
1/2/14
AMS 700 Inflatable Penile ProsthesisAmerican Medical Systems, Inc.
Minnetonka, MN 55343
Proposed addition of an alternative method (automated) for applying a plug to the kink resistant tubing during the manufacturing application of an antimicrobial surface treatment.
P980016/S453
1/16/14
Evera S DR/VR ICD, Evera XT DR/VR ICD, Maximo II ICD, Protecta ICD, Protecta XT ICD, Secura ICD, Virtuoso II DR/VR ICDsMedtronic, Inc.
Mounds View, MN
55112
Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products.
P980035/S356
1/8/14
ADAPTA, VERSA, SENSIA Implantable Pulse GeneratorsMedtronic, Inc.
Mounds View, MN
55112
Use of SPACE Software Release 6.0 (Build 7), a statistical process control (SPC) software.
P980035/S359
1/16/14
Adapta, Versa, Sensia IPG, Advisa DR/DR MRI IPG, Relia IPGMedtronic, Inc.
Mounds View, MN
55112
Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products.
P980035/S361
1/22/14
Adapta, Versa, Sensia IPG; Advisa DR IPG;. Advisa DR MRI IPG; Relia IPGMedtronic, Inc.
Mounds View, MN
55112
New supplier for the molding compound used in the manufacturing of capacitors for the hybrid assemblies.
P980035/S362
1/16/14
Advisa DR IPG, Advisa DR MRI IPGMedtronic CRDM
Mounds View, MN
55112
Use of the Incoming Inspection (Receiving Batch on Purchase order) work flow with SAP Quality Management (QM) Module.
P980044/S017
1/14/14
SUPARTZ Joint Fluid TherapySeikagaku Corporation
Tokyo, Japan
100-0005
Contract laboratory change.
P980050/S089
1/16/14
Transvene CS/SVC LeadMedtronic, Inc.
Mounds View, MN
55112
Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products.
P980050/S090
1/16/14
Transvene CS/SVC LeadMedtronic CRDM
Mounds View, MN
55112
Use of the Incoming Inspection (Receiving Batch on Purchase order) work flow with SAP Quality Management (QM) Module.
P990001/S116
1/16/14
Vita VVIR IPGMedtronic, Inc.
Mounds View, MN
55112
Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products.
P990025/S039
1/24/14
NaviStar, NaviStar RMT, EZ Steer Nay Catheters and BWI CablesBiosense Webster, Inc.
Diamond Bar, CA
91765
Change in the sterilization release method for Biosense Webster catheters and cables.
P990038/S019
1/10/14
ETI-MAK-2 PLUS and HBsAg Confirmatory TestDiaSorin Inc.
Stillwater, MN 55082
Minor labeling change and changes in location from one room to another room within the same building for the manufacturing activities of manual kit packaging, sampling of incoming human serum/plasma units, and heat inactivation of HBsAg positive samples.
P990041/S018
1/10/14
ETI-AB-EBK PLUSDiaSorin Inc.
Stillwater, MN 55082
Minor labeling change and changes in location from one room to another room within the same building for the manufacturing activities of manual kit packaging, sampling of incoming human serum/plasma units, and heat inactivation of HBsAg positive samples.
P990042/S015
1/10/14
ETI-AB-AUK PLUSDiaSorin Inc.
Stillwater, MN 55082
Minor labeling change and changes in location from one room to another room within the same building for the manufacturing activities of manual kit packaging, sampling of incoming human serum/plasma units, and heat inactivation of HBsAg positive samples.
P990043/S019
1/10/14
ETI-EBK PLUSDiaSorin Inc.
Stillwater, MN 55082
Minor labeling change and changes in location from one room to another room within the same building for the manufacturing activities of manual kit packaging, sampling of incoming human serum/plasma units, and heat inactivation of HBsAg positive samples.
P990044/S016
1/10/14
ETI-CORE-IGMK PLUSDiaSorin Inc.
Stillwater, MN 55082
Minor labeling change and changes in location from one room to another room within the same building for the manufacturing activities of manual kit packaging, sampling of incoming human serum/plasma units, and heat inactivation of HBsAg positive samples.
P990045/S016
1/10/14
ETI-AB-COREK PLUSDiaSorin Inc.
Stillwater, MN 55082
Minor labeling change and changes in location from one room to another room within the same building for the manufacturing activities of manual kit packaging, sampling of incoming human serum/plasma units, and heat inactivation of HBsAg positive samples.
P990046/S037
1/24/14
Open Pivot Heart Valve and Aortic Valve GraftMedtronic Inc.
CardioVascular
Mounds View, MN
55112
Alternative to batch testing for bacterial endotoxin testing (BET).
P990071/S025
1/24/14
RF Generator and Accessories/Accessory CablesBiosense Webster, Inc.
Diamond Bar, CA
91765
Change in the sterilization release method for Biosense Webster catheters and cables.
P990081/S025
1/22/14
PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary AntibodyVentana Medical Systems, Inc.
Tucson, AZ
85755
Addition of a new supplier for PCBAs (Printed Circuit Board Assemblies) used in the manufacture of the BenchMark ULTRA Instrument.
P990081/S026
1/23/14
PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary AntibodyVentana Medical Systems, Inc.
Tucson, AZ
85755
Addition of a new supplier for a subassembly used in the manufacture of the BenchMark XT Instrument.
P000006/S035
1/17/14
Titan Inflatable Penile ProsthesisColoplast Corp
Minneapolis, MN
55411
Change to the mold used in the manufacture of the connector sleeve.
P000012/S047
1/9/14
COBAS® AMPLICOR® Hepatitis C Virus Test version 2.0 and COBAS® AmpliPrep/COBAS® AMPLICOR® HCV Test version 2.0Roche Molecular Systems, Inc.
Pleasanton, CA 94588
Change to discontinue chemical testing for potassium concentration in master mixes.
P000025/S074
1/17/14
COMBI 40+ Cochlear Implant System (Mi1000 MED-EL CONCERT and SONATATI100)MED-EL Elektro-Medizinische Geräte GmbH
Innsbruck - Fürstenweg 77a
Austria
A-6020
Changes in the vacuum bake-out process and the preparation of in-process test samples.
P000046/S021
1/24/14
Staarvisc, Optivisc, and Anikavisc Sodim HyaluronateAnika Therapeutics, Inc.
Bedford, MA 01730
Change to the manufacturing process with regard to the device’s packaging.
P000046/S022
1/23/14
Staarvisc II, ShellgelAnika Therapeutics, Inc.
Bedford, MA 01730
Addition of a new cannula supplier.
P000053/S049
1/2/14
AMS 800 Urinary ControlAmerican Medical Systems, Inc.
Minnetonka, MN 55343
Proposed addition of an alternative method (automated) for applying a plug to the kink resistant tubing during the manufacturing application of an antimicrobial surface treatment.
P010015/S228
1/16/14
Attain Bipolar OTW Lead, Consulta CRT-P, Syncra CRT-PMedtronic, Inc.
Mounds View, MN
55112
Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products.
P010015/S230
1/22/14
Consulta CRT-P, Syncra CRT-PMedtronic, Inc.
Mounds View, MN
55112
New supplier for the molding compound used in the manufacturing of capacitors for the hybrid assemblies.
P010015/S231
1/16/14
Attain Bipolar OTW Lead, Consulta CRT-P, Left Ventricular Pacing Lead, Syncra CRT-PMedtronic CRDM
Mounds View, MN
55112
Use of the Incoming Inspection (Receiving Batch on Purchase order) work flow with SAP Quality Management (QM) Module.
P010030/S047
1/22/14
LifeVest Wearable DefibrillatorZoll Lifecor Corporation
Pittsburgh, PA 15238
New supplier for the therapy electrode gas generator base and therapy electrode gas generator enclosure cover.
P010031/S415
1/16/14
Brava CRT-D, Concerto II CRT-D, Consulta ICD, Maximo II CRT-D, Protecta XT CRT-D , Viva S CRT-D, Viva XT CRT-DMedtronic, Inc.
Mounds View, MN
55112
Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products.
P010033/S023
1/31/14
QuantiFERON®-TB GoldCellestis Incorporated
Valencia, CA 91355
Changes to incorporate new branding in the labeling, tighten an in-process QC specification for the blood collection tubes, and add steps to a raw material acceptance procedure.
P010041/S047
1/23/14
Carpentier-Edwards S.A.V. Aortic Porcine BioprosthesisEdwards Lifesciences, LLC
Irvine, CA
92614
Change in the polyester cloth manufacturing aid.
P010047/S033
1/27/14
Progel Pleural Air Leak SealantNeomend Inc.
Irvine, CA
92618
Addition of a second source component supplier.
P010068/S038
1/24/14
Celsius DS, NaviStar DS, NaviStar RMT DS, EZ Steer Nav DS CathetersBiosense Webster, Inc.
Diamond Bar, CA
91765
Change in the sterilization release method for Biosense Webster catheters and cables.
P020004/S089
1/17/14
GORE® EXCLUDER® AAA EndoprosthesisW.L. Gore and Associates, Inc.
Flagstaff, AZ
86005
Alternate PTFE resin.
P020009/S114
1/29/14
Express2 Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Remove the metals content load test used for the monitoring of electropolishing solutions.
P020055/S013
1/23/14
Pathway Anti-c-KIT (9.7) Primary AntibodyVentana Medical Systems, Inc.
Tucson, AZ
85755
Addition of a new supplier for a subassembly used in the manufacture of the BenchMark XT Instrument.
P030009/S073
1/14/14
Integrity Coronary Stent SystemsMedtronic Vascular
Santa Rosa, CA 95403
Change to the bioburden test method.
P030017/S187
1/22/14
Precision Spectra Spinal Cord Stimulator SystemBoston Scientific Corporation
Canyon Loop
Valencia, CA 91355
Add an alternate qualified supplier for the printed circuit board assembly.
P030017/S188
1/22/14
Precision Spectra Spinal Cord Stimulator SystemBoston Scientific Corporation
Canyon Loop
Valencia, CA 91355
Add an alternate qualified supplier for the feedthrough component.
P030022/S028
1/13/14
Reflection Ceramic Acetabular Hip SystemSmith & Nephew, Incorporated
Memphis, TN 38116
Change to a different detergent chelating agent.
P030022/S029
1/13/14
Reflection Ceramic Acetabular Hip System (RCHS)Smith & Nephew, Incorporated
Memphis, TN 38116
Add new manufacturing equipment.
P030031/S058
1/24/14
Celsius ThermoCool, Celsius RMT ThermoCool CathetersBiosense Webster, Inc.
Diamond Bar, CA
91765
Change in the sterilization release method for Biosense Webster catheters and cables.
P030036/S068
1/16/14
Select Secure LeadsMedtronic, Inc.
Mounds View, MN
55112
Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products.
P030036/S069
1/16/14
SelectSecure LeadMedtronic CRDM
Mounds View, MN
55112
Use of the Incoming Inspection (Receiving Batch on Purchase order) work flow with SAP Quality Management (QM) Module.
P030050/S019
1/23/14
SCULPTRA and SCULPTRA AESTHETICValeant Pharmaceuticals North America LLC
Bridgewater, NJ 08807
Changes to the sieving yield range and a modification of the stirring system for clogging test.
P040016/S120
1/29/14
VeriFLEX (Liberte) Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Remove the metals content load test used for the monitoring of electropolishing solutions.
P040020/S052
1/13/14
AcrySof ReSTOR Multifocal Posterior Intraocular LensesAlcon Research, Ltd.
Fort Worth, TX 76134
Reduce frequency of a manufacturing inspection from a 100% inspection rate to a sample-based inspection plan for devices within a lot.
P040036/S041
1/24/14
NaviStar-, Navistar RMT-, EZ Steer- ThermoCool CathetersBiosense Webster, Inc.
Diamond Bar, CA
91765
Change in the sterilization release method for Biosense Webster catheters and cables.
P040044/S050
1/24/14
Mynx Vascular Closure Device Product Family, MynxGrip and MynxAceAccess Closure Inc.
Santa Clara, CA 95054
Changes to the Hydrogel drying process.
P050028/S038
1/9/14
COBAS® TaqMan HBV Test For Use With The High Pure System and COBAS® AmpliPrep/ COBAS® TaqMan® HBV Test version 2.0Roche Molecular Systems, Inc.
Pleasanton, CA 94588
Change to discontinue chemical testing for potassium concentration in master mixes.
P050028/S039
1/23/14
COBAS® TaqMan HBV Test For Use With The High Pure System and COBAS® AmpliPrep/COBAS® TaqMan® HBV Test version 2.0Roche Molecular Systems, Inc.
Pleasanton, CA 94588
Change to discontinue in-process testing for pH and visual inspection for a vialed component.
P050034/S012
1/15/14
Implantable Miniature TelescopeVisionCare Ophthalmic Technologies
Petah Tikva,
Israel
49130
Possibility of rework and retesting activities.
P050051/S025
1/9/14
ARCHITECT AUSABAbbott Laboratories
Abbott Park, IL 60064
Change to the purification process for antigens used in the manufacture of the ARCHITECT AUSAB assay.
P060006/S053
1/29/14
Express SD Renal Monorail Premounted Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Remove the metals content load test used for the monitoring of electropolishing solutions.
P060030/S038
1/9/14
COBAS® AmpliPrep/ COBAS® TaqMan® HCV Test and COBAS® TaqMan HCV Test version 2.0 For Use With The High Pure SystemRoche Molecular Systems, Inc.
Pleasanton, CA 94588
Change to discontinue chemical testing for potassium concentration in master mixes.
P060033/S085
1/14/14
Endeavor Sprint Zotarolimus-Eluting Coronary Stent SystemMedtronic Vascular
Santa Rosa, CA 95403
Change to the bioburden test method.
P060039/S054
1/16/14
Attain StarFix LeadsMedtronic, Inc.
Mounds View, MN
55112
Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products.
P060039/S055
1/16/14
Attain StarFix LeadMedtronic CRDM
Mounds View, MN
55112
Use of the Incoming Inspection (Receiving Batch on Purchase order) work flow with SAP Quality Management (QM) Module.
P070004/S007
1/8/14
Sientra Silicone Gel Breast ImplantsSientra, Inc.
Santa Barbara, CA
93117
Changes to the material of the breast implant molds.
P070015/S118
1/8/14
XIENCE V Everolimus Eluting Coronary Stent System on both RX (Rapid Exchange) and OTW (Over the Wire) Platforms and XIENCE nano Everolimus Eluting Coronary Stent System on the RX PlatformAbbott Vascular
Temecula, CA 92590
Modifications to the sampling plan for XIENCE final release testing.
P070027/S037
1/14/14
Talent AAA Stent Graft with Xcelerant Hydro Delivery SystemMedtronic Vascular
Santa Rosa, CA 95403
Change to the bioburden test method.
P080006/S064
1/16/14
Attain Ability LeadsMedtronic, Inc.
Mounds View, MN
55112
Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products.
P080006/S065
1/16/14
Attain Ability LeadMedtronic CRDM
Mounds View, MN
55112
Use of the Incoming Inspection (Receiving Batch on Purchase order) work flow with SAP Quality Management (QM) Module.
P080025/S062
1/22/14
SNS Bowel Extensions; SNS Bowel LeadsMedtronic Neuromodulation
Minneapolis, MN
55432
Manufacturing change associated with incoming inspection activities.
P090003/S030
1/29/14
Express LD Iliac Premounted Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Remove the metals content load test used for the monitoring of electropolishing solutions.
P090006/S012
1/14/14
Complete SE Iliac Vascular Stent SystemMedtronic Vascular
Santa Rosa, CA 95403
Change to the bioburden test method.
P090013/S121
1/8/14
CAPSUREFIX MRI LeadMedtronic, Inc.
Mounds View, MN
55112
Use of SPACE Software Release 6.0 (Build 7), a statistical process control (SPC) software.
P090013/S123
1/16/14
CapSureFix MRI Lead, Revo MRI IPGMedtronic, Inc.
Mounds View, MN
55112
Relocation for the performance of selected inspection activities used for incoming/receiving for selected Medtronic Cardiac Rhythm Disease Management (CRDM) products.
P090013/S125
1/22/14
Revo MRI IPGMedtronic, Inc.
Mounds View, MN
55112
New supplier for the molding compound used in the manufacturing of capacitors for the hybrid assemblies.
P090013/S126
1/16/14
CapSureFix MRI Lead, Revo MRI IPGMedtronic CRDM
Mounds View, MN
55112
Use of the Incoming Inspection (Receiving Batch on Purchase order) work flow with SAP Quality Management (QM) Module.
P100021/S031
1/14/14
Endurant Stent Graft SystemMedtronic Vascular
Santa Rosa, CA 95403
Change to the bioburden test method.
P100026/S007
1/24/14
NeuroPace RNS SystemNeuroPace, Inc.
Mountain View, CA
94043
Implement a new database used to collect and store manufacturing test data.
P100027/S014
1/22/14
INFORM HER2 Dual ISH DNA ProbeVentana Medical Systems, Inc.
Tucson, AZ
85755
Addition of a new supplier for PCBAs (Printed Circuit Board Assemblies) used in the manufacture of the BenchMark ULTRA Instrument.
P100027/S015
1/23/14
INFORM HER2 Dual ISH DNA Probe CocktailVentana Medical Systems, Inc.
Tucson, AZ
85755
Addition of a new supplier for a subassembly used in the manufacture of the BenchMark XT Instrument.
P100040/S015
1/14/14
Valiant Thoracic Stent Graft with the Captivia Delivery SystemMedtronic Vascular
Santa Rosa, CA 95403
Change to the bioburden test method.
P110011/S006
1/14/14
Assurant Cobalt Iliac Balloon-Expandable Stent SystemMedtronic Vascular
Santa Rosa, CA 95403
Change to the bioburden test method.
P110013/S032
1/14/14
Resolute Integrity Coronary Stent SystemMedtronic Vascular
Santa Rosa, CA 95403
Change to the bioburden test method.
P110019/S059
1/8/14
XIENCE PRIME (XIENCE PRIME and XIENCE PRIME Long Lengths [LL]) on the RX platformAbbott Vascular
Temecula, CA 92590
Modifications to the sampling plan for XIENCE final release testing.
P110020/S011
1/9/14
cobas® 4800 BRAF V600 Mutation TestRoche Molecular Systems, Inc.
Pleasanton, CA 94588
Change to discontinue chemical testing for potassium concentration in master mixes.
P110040/S002
1/14/14
Complete SE SFA/PPA Vascular Stent SystemMedtronic Vascular
Santa Rosa, CA 95403
Change to the bioburden test method.
P110042/S024
1/22/14
S-ICD® SystemCameron Health, Inc.
San Clemente, CA
92673
Additional system used in manufacturing operations for the S-ICD® System.
P110042/S025
1/31/14
S-ICD SystemCameron Health, Inc.
San Clemente, CA
92673
Use of a two-part epoxy on the high voltage capacitor used in the S-ICD System.

Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 43

Summary of PMA Originals Under Review
Total Under Review: 52
Total Active: 23
Total On Hold: 29

Summary of PMA Supplements Under Review
Total Under Review: 582
Total Active: 394
Total On Hold: 188

Summary of All PMA Submissions Received
Originals: 0
Supplements: 54

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 43
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 185
FDA Time: 123.9 Days MFR Time: 61.1 Days

Page Last Updated: 06/17/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.