Medical Devices

December 2013 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
P130006
12/5/13
GORE® VIABAHN® Endoprosthesis & GORE® VIABAHN® Endoprosthesis with Heparin BioActive SurfaceW.L. Gore and Associates
Flagstaff, AZ
86001
Approval for the GORE® VIABAHN® Endoprosthesis and the GORE® VIABAHN® Endoprosthesis with Heparin BioActive Surface. This device is indicated for the treatment of stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous (AV) access grafts.

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
N16837/S011
12/23/13
180-Day
Artegraft Bovine Collage GraftArtegraft, Inc.
North Brunswick, NJ
08902
Approval for a manufacturing site located in North Brunswick, New Jersey.
P820003/S123
12/11/13
180-Day
Medtronic Cables and AdaptorsMedtronic, Inc.
Mounds View, MN
55112
Approval for a manufacturing site located at Technical Services for Electronics, Inc., in  Jackson, Minnesota.
P830061/S089
12/24/13
180-Day
Capsure Lead, Capsure SP Lead, Vitatron Crystalline Lead, Vitatron Excellence PS+ LeadMedtronic, Inc.
Mounds View, MN 55112
Approval for a re-packaging/re-labeling site located at Medtronic in  Memphis, Tennessee.
P840001/S241
12/11/13
135-Day
Spinal Cord Stimulation (Itrel, Synergy, Synergy Versitrel, Restore,
RestorePrime, Restore Advanced, Prime Advanced, Restore Ultra, ENS)
Medtronic Neuromodulation
Minneapolis, MN 55432
Approval for change to an automated destructive test analysis process.
P850089/S095
12/24/13
180-Day
Capsure SP Novus lead, Capsure SP Z lead, Capsure Z Novus lead, Impulse II leadMedtronic, Inc.
Mounds View, MN 55112
Approval for a re-packaging/re-labeling site located at Medtronic in  Memphis, Tennessee.
P870072/S055
12/10/13
180-Day
Thoratec® Ventricular Assist Device (VAD) System PVAD Isolation ModuleThoratec Corporation
Pleasanton, CA 94588
Approval of the addition of a PVAD Isolation Module (PIM) for use with the PVAD and the dual drive console (DDC).
P870072/S057
12/18/13
Special
Thoratec Ventricular Assist Device (VAD) SystemThoratec Corporation
Pleasanton, CA 94588
Approval for a change to the final inspection of the Thoratec Ventricular Assist Device (VAD) System.
P890003/S272
12/24/13
180-Day
Capsure LeadMedtronic, Inc.
Mounds View, MN 55112
Approval for a re-packaging/re-labeling site located at Medtronic in  Memphis, Tennessee.
P890003/S281
12/11/13
180-Day
Medtronic Cables and AdaptorsMedtronic, Inc.
Mounds View, MN
55112
Approval for a manufacturing site located at Technical Services for Electronics, Inc., in  Jackson, Minnesota.
P900061/S120
12/14/13
180-Day
Epicardial Patch LeadMedtronic, Inc.
Mounds View, MN 55112
Approval for a re-packaging/re-labeling site located at Medtronic in  Memphis, Tennessee.
P910023/S321
12/17/13
Real-Time
Ellipse Family of ICDsSt. Jude Medical
Sylmar, CA
91342
Approval for a modification to the output flex assembly in the Ellipse family of ICDs.
P920015/S109
12/24/13
180-Day
Sprint Quattro Lead, Subcutaneous Lead, Transvene SVC LeadMedtronic, Inc.
Mounds View, MN 55112
Approval for a re-packaging/re-labeling site located at Medtronic in  Memphis, Tennessee.
P920047/S063
12/5/13
Special
Maestro 3000 Cardiac Ablation SystemBoston Scientific Corporation
San Jose, CA
95134
Approval for minor labeling changes, including updates in accordance with IEC 60601-1 third edition.
P930039/S085
12/24/13
180-Day
Capsurefix Lead, Capsurefix Novus Lead, Surefix Lead, Vitatron Crystalline LeadMedtronic, Inc.
Mounds View, MN 55112
Approval for a re-packaging/re-labeling site located at Medtronic in  Memphis, Tennessee.
P950024/S048
12/24/13
180-Day
Capsure Epicardial Pacing LeadMedtronic, Inc.
Mounds View, MN 55112
Approval for a re-packaging/re-labeling site located at Medtronic in  Memphis, Tennessee.
P960009/S172
12/11/13
135-Day
Activa Deep Brain Stimulation (Activa PC, Activa SC, Activa RC,
Kinetra, Soletra)
Medtronic Neuromodulation
Minneapolis, MN 55432
Approval for change to an automated destructive test analysis process.
P960040/S297
12/23/13
Real-Time
PUNCTUA® ICD ENERGEN® ICD,
INCEPTA® ICD, TELIGEN® ICD
Boston Scientific Corporation
St. Paul, MN
55112
Approval for the battery feedthru (FT) materials of the  devices.
P960058/S103
12/24/13
135-Day
HiResolution Bionic Ear SystemAdvanced Bionics
Sylmar, CA
91342
Approval for an alternate resin material for the electrode wires.
P970004/S156
12/11/13
135-Day
Interstim Therapy for Urinary ControlMedtronic Neuromodulation
Minneapolis, MN 55432
Approval for change to an automated destructive test analysis process.
P970051/S112
12/20/13
Real-Time
Nucleus Cochlear Implant System: CP900 Series Rechargeable BatteriesCochlear Americas
Centennial, CO 80111
Approval for introduction of the Rechargeable Batteries (A29 and A30) intended for use with the CP900 series of sound processor (CP910 and CP920).
P980003/S045
12/5/13
Special
Maestro 3000 Cardiac Ablation SystemBoston Scientific Corporation
San Jose, CA
95134
Approval for minor labeling changes, including updates in accordance with IEC 60601-1 third edition.
P980016/S412
12/24/13
180-Day
Maximo II ICD, Protecta ICD, Evera S DR, Evera S VR, Evera XT DR, Evera XT VR, Protecta XT ICD, Secura ICD, Virtuoso II DR/VR ICDMedtronic, Inc.
Mounds View, MN 55112
Approval for a re-packaging/re-labeling site located at Medtronic in  Memphis, Tennessee.
P980022/S119
12/26/13
180-Day
Paradigm Real-Time Revel System;
Guardian Real-Time System; MiniLink Real-Time System
Medtronic MiniMed
Northridge, CA 91325
Approval for a new Watertight Tester accessory device as well as labeling changes related to new cleaning and disinfection protocols for the MiniLink Transmitter and new Watertight Tester. The MiniLink Transmitter (model MMT-7703) and the Watertight Tester (model MMT-7726) are components of the Paradigm Real-Time Revel System, Guardian RealTime System, and Mini Link Real-Time System.
P980022/S142
12/6/13
Special
Paradigm REAL-Time System, Paradigm REAL-Time Revel System, Guardian REAL-Time CGM System, MiniLink REAL-Time System, iPro Recorder CGM System, iPro2 Professional CGM SystemMedtronic MiniMed, Inc.
Northridge, CA 91325
Approval of product specification requirements for the glucose oxidase material used in the Sof-Sensors (Models: MMT-7002 and MMT-7003) and the Enlite Sensor (Model: MMT-7008).
P980022/S149
12/24/13
Special
Paradigm® REAL-Time System and Paradigm® REAL-Time Revel SystemMedtrronic Minimed, Inc.
Northridge, CA 91325
Approval for a labeling change to the errata sheet to provide additional information about potential water damage to the Paradigm REAL-Time Insulin Pumps (Models: MMT-522, MMT-522K, MMT-722 and MMT-722K) and the Paradigm REAL-Time Revel Insulin Pumps (Models: MMT-523, MMT-523K, MMT-723 and MMT-723K).
P980035/S319
12/24/13
180-Day
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa MRI IPG, Relia IPGMedtronic, Inc.
Mounds View, MN 55112
Approval for a re-packaging/re-labeling site located at Medtronic in  Memphis, Tennessee.
P980035/S334
12/6/13
180-Day
Advisa DR MRI A2DR01 Implantable Pulse Generator, Software Model 9995Medtronic, Inc.
Mounds View, MN 55112
Approval of labeling changes to remove the restriction stating that “the patient must be positioned within the bore such that the isocenter (center of the MRI bore) is superior to the C1 vertebra or inferior to the T12 vertebra” as well as to remove the requirement that MRI scans not be performed on patients with other previously implanted medical devices.
P980050/S081
12/24/13
180-Day
Transvene LeadMedtronic, Inc.
Mounds View, MN 55112
Approval for a re-packaging/re-labeling site located at Medtronic in  Memphis, Tennessee.
P990040/S017
12/24/13
135-Day
TRUFILL n-Butyl Cyanoacrylate Liquid Embolic SystemCodman & Shurtleff, Inc.
Raynham, MA 02767
Approval to change the supplier for a chemical composition test.
P990052/S023
12/19/13
Real-Time
Vibrant Soundbridge Middle Ear Implant System;
VORP Sizer Kit
MED-EL Corporation
Durham, NC
27713
Approval for a VORP Sizer Kit. This includes a minor modification (material change) to the VORP template and the addition of the Floating Mass Transducer (FMT) sizer for optional use during Vibrant Soundbridge implantation surgery.
P000025/S067
12/5/13
180-Day
COMBI 40+ Cochlear Implant System
MAESTRO 4.1 Software
MED-EL Corporation
Durham, NC
27713
Approval for the MAESTRO 4.1 software, an updated version of the fitting software intended for use with the MED-EL cochlear implant system.
P000054/S040
12/6/13
Real-Time
INFUSE® Bone GraftMedtronic Sofamor Danek USA, Incorporated
Memphis, TN 38132
Approval for extension of the rhBMP-2 drug substance expiration date from 60 to 72 months using the approved expiration date modification protocol. The device, as modified, will be marketed under the trade name INFUSE®Bone Graft and is indicated for the following: “treating acute, open tibial shaft fractures that have been stabilized with IM nail fixation after appropriate wound management.” INFUSE Bone Graft must be applied within 14 days after the initial fracture. Prospective patients should be skeletally mature.
P000058/S054
12/6/13
Real-Time
INFUSE® Bone Graft/LT-Cage® Lumbar Tapered Fusion DeviceMedtronic Sofamor Danek USA, Incorporated
Memphis, TN 38132
Approval for extension of the rhBMP-2 drug substance expiration date from 60 to 72 months using the approved expiration date modification protocol. The device, as modified, will be marketed under the trade name INFUSE® Bone Graft/LT-Cage® Lumbar Tapered Fusion Devices and is indicated for the following:  “spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L4-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history, function deficit and/or neurological deficit and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level.” InFUSE® Bone Graft/LT-CAGE® devices are to be implanted via an open anterior or a laparoscopic approach. Patients receiving the InFUSE® Bone Graft/ LT-CAGE® Lumbar Tapered Fusion Device should have had at least six months of nonoperative treatment prior to treatment with the InFUSE® Bone Graft/LT-CAGE® device.
P010012/S332
12/23/13
Real-Time
PUNCTUA® CRT-D, ENERGEN® CRT-D, INCEPTA®
CRT-D, COGNIS® CRT-D
Boston Scientific Corporation
St. Paul, MN
55112
Approval for the battery feedthru (FT) materials of the  devices.
P010015/S197
12/24/13
180-Day
Attain Bipolar OTW Lead, Consulta CRT-P, Left Ventricular Pacing Lead, Syncra CRT-PMedtronic, Inc.
Mounds View, MN 55112
Approval for a re-packaging/re-labeling site located at Medtronic in  Memphis, Tennessee.
P010031/S372
12/24/13
180-Day
Concerto II CRT-D, Consulta DF-4 ICD, Consulta ICD, Maximo II CRT-D, Protecta CRT-D, Protecta XT CRT-D, Brava CRT-D, Viva S CRT-DMedtronic, Inc.
Mounds View, MN 55112
Approval for a re-packaging/re-labeling site located at Medtronic in  Memphis, Tennessee.
P020022/S010
12/23/13
Real-Time
VERSANT® HCV RNA 3.0 Assay (bDNA)Siemens Healthcare Diagnostics
Berkeley, CA
94702
Approval for extension of the shelf-life of the VERSANT® HCV RNA 3.0 Assay (bDNA) from 12 to 18 months.
P020025/S049
12/5/13
Special
Maestro 3000 Cardiac Ablation SystemBoston Scientific Corporation
San Jose, CA
95134
Approval for minor labeling changes, including updates in accordance with IEC 60601-1 third edition.
P030011/S021
12/24/13
180-Day
The Syncardia Temporary Total Artificial Heart (TAH-t) Companion 2 Driver SystemSyncardia Systems, Inc.
Tucson, AZ
85713
Approval of the post-approval study protocol.
P030036/S056
12/24/13
180-Day
Select Secure LeadMedtronic, Inc.
Mounds View, MN 55112
Approval for a re-packaging/re-labeling site located at Medtronic in  Memphis, Tennessee.
P040003/S013
12/16/13
Real-Time
InSightec ExAblate SystemInSightec, Ltd.
Tirat-Carmel, Israel
Approval for a minor software change of the ExAblate System to address the micro-switch error.
P040025/S014
12/23/13
180-Day
Olympic Cool-Cap SystemNatus Medical Incorporated
Seattle, WA
98108
Approval for a Post-Approval Study (Registry) Labeling Update for the Olympic Cool-Cap System.
P050053/S031
12/6/13
Real-Time
INFUSE® Bone GraftMedtronic Sofamor Danek USA, Incorporated
Memphis, TN 38132
Approval for extension of the rhBMP-2 drug substance expiration date from 60 to 72 months using the approved expiration date modification protocol. The device, as modified, will be marketed under the trade name INFUSE® Bone Graft and is indicated for the following: “an alternative to autogenous bone graft for sinus augmentations, and for localized alveolar ridge augmentations for defects associated with extraction sockets.”   
P060039/S044
12/24/13
180-Day
Attain Starfix LeadMedtronic, Inc.
Mounds View, MN 55112
Approval for a re-packaging/re-labeling site located at Medtronic in  Memphis, Tennessee.
P070004/S006
12/18/13
Real-Time
Sientra Silicone Gel Breast ImplantsSientra Incorporated
Santa Barbara, CA 93117
Approval for additional implant styles that incorporate changes to the approved PMA devices and includes the following styles: 10610-LP; 10621-MP/HP; 10712-MP; 10722-HP; 20710-LP; 10710-LP; 20721-MP/HP; 10721-MP/HP; five additional sizes of the 10512-MP Style Implant; four additional sizes of the 10521-HP Style Implant; four additional sizes of the 20610-LP Style Implant; and eight additional sizes of the 20621-MP/HP Style Implant.
P070026/S020
12/9/13
Real-Time
DePuy CERAMAX® Ceramic Total Hip SystemDePuy Orthopaedics, Incorporated
Warsaw, IN
46581
Approval for the addition of Tri-Lock BPS Hip Stem to be used with the 36mm Femoral Heads.
P080006/S052
12/24/13
180-Day
Attain Ability LeadMedtronic, Inc.
Mounds View, MN 55112
Approval for a re-packaging/re-labeling site located at Medtronic in  Memphis, Tennessee.
P080006/S057
12/5/13
180-Day
Attain Ability Left Ventricular (LV) LeadMedtronic, Inc.
Mounds View, MN 54112
Approval of the post-approval study protocol.
P080025/S052
12/11/13
135-Day
Interstim Therapy for Bowel ControlMedtronic Neuromodulation
Minneapolis, MN 55432
Approval for change to an automated destructive test analysis process.
P090013/S091
12/24/13
180-Day
Capsurefix MRI Lead, Revo MRI IPGMedtronic, Inc.
Mounds View, MN 55112
Approval for a re-packaging/re-labeling site located at Medtronic in  Memphis, Tennessee.
P090013/S105
12/6/13
180-Day
Revo MRI Model RVDR01 IPG
EnRhythm MRI SureScan Model EMDR01 IPG
Medtronic, Inc.
Mounds View, MN 55112
Approval of labeling changes to remove the restriction stating that “the patient must be positioned within the bore such that the isocenter (center of the MRI bore) is superior to the C1 vertebra or inferior to the T12 vertebra” as well as to remove the requirement that MRI scans not be performed on patients with other previously implanted medical devices.
P100005/S003
12/2/13
180-Day
M-Vu® Algorithm EngineVuCOMP, Inc.
Plano, TX
75093
Approval for M-Vu Algorithm Engine version 3.0.0.0.
P100010/S025
12/12/13
135-Day
Arctic Front Cryoablation Catheter, Arctic Front Advance Cryoablation CatheterMedtronic AF Solutions
Mounds View, MN 55112
Approval for the implementation of an alternative procedure involving the inflation and deflation of balloons contained in the device during the manufacturing process.
P100010/S032
12/18/13
180-Day
The Arctic Front Cryocatheter SystemMedtronic Cryocath
Quebec, Canada
H9R 5Z8
Approval of the post-approval study protocol.
P100020/S012
12/16/13
Real-Time
cobas® HPV TestRoche Molecular Systems, Inc.
Pleasanton, CA 94588
Approval for a change to the software of the cobas z480 Amplification/ Detection Analyzer, which is a component of the cobas 4800 System.
P100031/S008
12/20/13
180-Day
Elecsys® Anti-HBc Immunoassay and Elecsys® PreciControl Anti-HBcRoche Diagnostics
Indianapolis, IN 46250
Approval for the migration of claims from the FDA approved Elecsys Anti-HBc Immunoassay and Elecsys PreciControl Anti-HBc on the MODULAR ANALYTICS E170 to the cobas e 601 immunoassay analyzer. The device, as modified, will be marketed under the trade name Elecsys Anti-HBc Immunoassay and Elecsys PreciControl Anti-HBc and is indicated for: Elecsys Anti-HBc Immunoassay The Elecsys Anti-HBc immunoassay is for the in vitro qualitative determination of total antibodies to hepatitis B core antigen (anti-HBc) in human serum and plasma (lithium heparin, sodium citrate, KrEDTA) in adult patients with the symptoms of hepatitis or who may be at risk for hepatitis B virus (HBV) infection. The detection of total anti-HBc is indicative of a laboratory diagnosis for HBV infection. Further HBV serological marker testing is required to define the specific disease state. The Elecsys Anti-HBc immunoassay's performance has not been established for the monitoring of HBV disease or therapy. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the MODULAR ANALYTICS E 170, cobas e 60 I and co bas e 602 immunoassay analyzers. Elecsys PreciControl Anti-HBc Elecsys PreciControl Anti-HBc is used for quality control of the Elecsys Anti-HBc immunoassay on the MODULAR ANALYTICS E 170, cobas e 60 I and cobas e 602 immunoassay analyzers.
P100032/S007
12/19/13
180-Day
Elecsys® Anti-HBc Immunoassay and Elecsys® PreciControl Anti-HBcRoche Diagnostics
Indianapolis, IN 46250
Approval for the migration of claims from the FDA approved Elecsys Anti-HBc Immunoassay and Elecsys PreciControl Anti-HBc on the Elecsys 2010 Analyzer to the cobas e 411 immunoassay analyzer. The device, as modified, will be marketed under the trade name Elecsys Anti-HBc Immunoassay and Elecsys PreciControl Anti-HBc and is indicated for: Elecsys Anti-HBc Immunoassay The Elecsys Anti-HBc immunoassay is intended for the in vitro qualitative determination of total antibodies to hepatitis B core antigen (anti-HBc) in human serum and plasma (lithium heparin, sodium citrate, K2-EDTA) in adult patients with the symptoms of hepatitis or who may be at risk for hepatitis B (HBV) infection. The detection of total anti-HBc is indicative of a laboratory diagnosis for HBV infection. Further HBV serological marker testing is required to define the specific disease state. The Elecsys Anti-HBc immunoassay's performance has not been established for the monitoring of HBV disease or therapy.  The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Elecsys 2010 and the cobas e 411 immunoassay analyzers. Elecsys PreciControl Anti-HBc Elecsys PreciContro1 Anti-HBc is used for quality control of the Elecsys Anti-HBc immunoassay on the Elecsys 2010 and the cobas e411 immunoassay analyzers.
P100047/S020
12/20/13
180-Day
HeartWare® Ventricular Assist SystemHeartWare, Inc.
Miami Lakes, FL 33014
Approval for a new monitor for the HeartWare® Ventricular Assist System. The monitor will be manufactured by Xplore Technologies, Austin, Texas.
P100049/S006
12/19/13
Real-Time
LINX® Reflux Management SystemTorax Medical, Inc.
Shoreview, MN 55126
Approval for an update to the labeling for the LINX device regarding exposure to MRI scans.
P110004/S001
12/19/13
NIRxcell CoCr Coronary Stent on RX SystemMedinol Ltd.
Tel Aviv, Israel
61581
Approval for modifications to the stent delivery system. The device, as modified, will be marketed under the trade name NIRxcell CoCr Coronary Stent on RX System and is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease associated with stenotic lesions in de novo native coronary arteries (length ≤30mm) with a reference vessel diameter of 2.50mm to 4.00mm.
P110013/S021
12/12/13
135-Day
Resolute Integrity Zotarolimus-Eluting Coronary Stent SystemMedtronic Vascular
Santa Rosa, CA 95403
Approval for an alternate supplier for the C10 and C19 polymers.
P110016/S008
12/18/13
Panel-Track
Therapy Cool Flex Ablation CatheterSt. Jude Medical, Inc.
Irvine, CA
92614
Approval for the Therapy Cool Flex Ablation Catheter. This device is indicated for use with the compatible Irrigation pump and 1500T9-CP Radiofrequency (RF) Generator at a maximum of 50 watts. The catheter is intended for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation and ablation) for the treatment of typical atrial flutter.
P110019/S050
12/19/13
180-Day
XIENCE PRIME™ Everolimus Eluting Coronary Stent System; XIENCE PRIME™ LL Everolimus Eluting Coronary Stent System; XIENCE Xpedition™ Everolimus Eluting Coronary Stent System; XIENCE Xpedition™ LL Everolimus Eluting Coronary Stent System; XIENCE Xpedition™ SV Everolimus Eluting Coronary Stent SystemAbbott Vascular, Inc.
Temecula, CA 92589
Approval for a labeling change to extend the shelf life to 36 months for the RX platforms of the devices.
P110022/S008
12/20/13
180-Day
Elecsys® Anti-HBc IgM Immunoassay and Elecsys® PreciControl Anti-HBc lgMRoche Diagnostics
Indianapolis, IN 46250
Approval for the migration of claims from the FDA approved Elecsys Anti-HBc IgM Immunoassay and Elecsys PreciControl Anti-HBc IgM on the cobas e 601 to the cobas e 602 immunoassay analyzer. The device, as modified, will be marketed under the trade name Elecsys Anti-HBc IgM Immunoassay and Elecsys PreciControl Anti-HBc IgM and is indicated for: Elecsys Anti-HBc lgM Immunoassay The Elecsys Anti-HBc lgM immunoassay is intended for the in vitro qualitative determination ofigM antibodies to hepatitis B core antigen (anti-HBc IgM) in human serum or plasma (potassium EDTA, lithium heparin, sodium heparin, sodium citrate) in adult patients with symptoms of hepatitis or who may be at risk for hepatitis B (HBV) infection.  The presence of anti-HBc IgM, in conjunction with other laboratory results and clinical information, is indicative of acute or recent hepatitis B virus (HBV) infection. The Elecsys Anti-Hbc lgM immunoassay's performance has not been established for the monitoring of HBV disease or therapy. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the cobas e 601 and cobas e 602 immunoassay analyzers.  Elecsys PreciControl Anti-HBc Elecsys PreciControl Anti-HBc IgM is used for quality control of the Elecsys Anti-HBc IgM immunoassay on the cobas e 601  and cobas e 602 immunoassay analyzers.
P110039/S004
12/17/13
Real-Time
InSightec ExAblate SystemInSightec, Ltd.
Tirat Carmel, Israel
39120
Approval for a minor software change of the ExAblate System to address the micro-switch error.
P120006/S007
12/13/13
Real-Time
Ovation Prime Abdominal Stent Graft SystemTriVascular, Inc.
Santa Rosa, CA 95403
Approval for modifications to the stopcock value, which is being replaced by the California Valve, and the new supplier for the valve. The device, as modified, will be marketed under the trade name Ovation Prime Abdominal Stent Graft System and is indicated for treatment of patients with abdominal aortic aneurysms having the vascular morphology suitable for endovascular repair, including: 1) Adequate iliac/femoral access compatible with vascular access techniques, devices, and/or accessories; 2) Non-aneurysmal proximal aortic neck: a) with a length of at least 7 mm proximal to the aneurysm; b) with an inner wall diameter of no less than 16 mm and no greater than 30 mm; and c) with an aortic angle of ≤ 60 degrees if proximal neck is ≥ 10 mm and ≤ 45 degrees if proximal neck is < 10 mm; and 3) Adequate distal iliac landing zone: a) with a length of at least 10 mm; and b) with an inner wall diameter of no less than 8 mm and no greater than 20 mm.
P120006/S008
12/2/13
Special
Ovation Prime Abdominal Stent Graft SystemTriVascular, Inc.
Santa Rosa, CA 95403
Approval for changes to Instructions for Use that add and strengthen CAUTION statements.
P120010/S002
12/6/13
Special
MiniMed 530G SystemMedtronic MiniMed, Inc.
Northridge, CA 91325
Approval of product specification requirements for the glucose oxidase material used in the Sof-Sensors (Models: MMT-7002 and MMT-7003) and the Enlite Sensor (Model: MMT-7008).

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

APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
P780007/S052
12/13/13
Polymacon Extended Wear Contact LensesCoopervision
Pleasanton, CA 94588
Manufacturing change to add a new quality test for manufacturing.
P810002/S088
12/19/13
St. Jude Mechanical Heart ValvesSt. Jude Medical
177 East County Road B
St. Paul, MN
55117
Implementation of a new sealing plate configuration and a change in sealing parameters for the Tyvek lid of the inner and outer trays for Mechanical Heart Valve packaging at one manufacturing facility.
P830055/S140
12/26/13
LCS Total Knee SystemDePuy Orthopaedics, Inc.
Warsaw, IN
46581
Change to the grit blasting process for the MBT Revision Cemented Tibial Tray.
P830061/S101
12/12/13
CapSure Sense and Vitatron Crystalline LeadMedtronic CRDM
Mounds View, MN 55112
Implementation of a software-related lead assembly process improvement, accommodating serial number variability.
P840001/S257
12/12/13
Restore Spinal Cord Stimulation (SCS) System. Lead Kit, Extension, Synergy, Synergy Versitrel, Synergy Plus, and Synergy Compact Plus SCS Systems, Low Impedance Lead Kits, Vectris SureScan MRI Implantable Neurostimulation System, Lead KitMedtronic, Inc.
Minneapolis, MN 55432
Make changes to the MRICS lean line integration.
P840001/S258
12/13/13
RestorePrime Implantable Neurostimulator, PrimeAdvanced Implantable Neurostimulator, Itrel 4 Restore Implantable Neurostimulator, RestoreUltra Implantable Neurostimulator, RestoreAdvanced Implantable Neurostimulator, RestoreSensor Implantable Neurostimulator, PrimeAdvanced SureScan MRI Neurostimulator, RestoreUltra SureScan MRI Rechargeable Neurostimulator, RestoreAdvanced SureScan MRI Rechargeable Neurostimulator, RestoreSensor SureScan MRI Rechargeable Neurostimulator, Pocket Adaptor Kits, Itrel 3 Implantable Neurostimulator, Synergy SureScan MRI Implantable NeurostimulatorMedtronic, Inc.
Minneapolis, MN 55432
Alternate Suppliers for INS Silicone Components
P850010/S048
12/16/13
Helistat Absorbable Collagen Hemostatic Agent (ACS)Integra LifeSciences Corporation
Plainsboro, NJ 08536
Additional packaging machine for the Helistat (ACS) product.
P860004/S201
12/13/13
SynchroMed II Implantable Infusion PumpMedtronic Inc.
Minneapolis, MN 55432
Change location of a supplier.for the top and bottom bridge assemblies
P860057/S115
12/19/13
Carpentier-Edwards PERIMOUNT Pericardial Aortic and Mitral BioprosthesesEdwards Lifesciences, LLC
Irvine, CA
92614
Addition of Terminal Liquid Sterilization ovens No. 6 and No. 7.
P870056/S063
12/19/13
Carpentier-Edwards Porcine Aortic and Mitral Bioprostheses, Porcine Valved ConduitEdwards Lifesciences, LLC
Irvine, CA
92614
Addition of Terminal Liquid Sterilization ovens No. 6 and No. 7.
P870072/S058
12/19/13
Thoratec Ventricular Assist Device SystemThoratec Corporation
Pleasanton, CA 94588
Use of a new coulometer in the manufacture of the polymer material.
P870077/S057
12/19/13
Carpentier-Edwards Duraflex Low Pressure Mitral BioprosthesesEdwards Lifesciences, LLC
Irvine, CA
92614
Addition of Terminal Liquid Sterilization ovens No. 6 and No. 7.
P880086/S236
12/4/13
Accent DR, Accent DR RF, Accent SR, Accent SR RFSt. Jude Medical, CRMD
Sylmar, CA
91342
Alternate Burn-In (BI) for the environmental screening during the manufacture of pacemaker and CRT-P hybrid assemblies.
P890003/S293
12/12/13
CapSure LeadMedtronic CRDM
Mounds View, MN 55112
Implementation of a software-related lead assembly process improvement, accommodating serial number variability.
P890003/S296
12/23/13
CapSure LeadMedtronic, Inc.
Mounds View MN, 55112
Update to the maximum sterilization load profile temperature for the devices.
P890023/S020
12/13/13
Ocufilcon D Extended Wear Contact LensesCoopervision
Pleasanton, CA 94588
Manufacturing change to add a new quality test for manufacturing.
P900056/S129
12/15/13
Rotablator Rotational Atherectomy SystemBoston Scientific, Corp.
Maple Grove, MN 55311
Removal of 34 of the 48 Quality Inspections within the RotaWire guidewire manufacturing process.
P900061/S125
12/23/13
Epicardial Patch LeadMedtronic, Inc.
Mounds View MN, 55112
Update to the maximum sterilization load profile temperature for the devices.
P910023/S324
12/17/13
Current, Current Accel, Current+, Ellipse, Fortify, and Fortify Assura Families of ICD DevicesSt. Jude Medical, CRMD
Sylmar, CA
91342
Alternate organic substrate manufacturer for use in the hybrid assemblies for the ICD and CRT-D devices.
P910056/S015
12/30/13
enVista® Hydrophobic Acrylic Intraocular LensBausch and Lomb Inc.
Irvine, CA
92618
Change in machinery used in the manufacturing of the vial used to package the enVista® intraocular lens.
P920015/S124
12/16/13
Sprint Quattro LeadsMedtronic, Inc.
Mounds View MN, 55112
Transfer of incoming inspection to a new site for a number of components used in the manufacture of Medtronic CRDM therapy delivery products.
P920015/S125
12/12/13
Subcutaneous and Transvene CS/SVC LeadMedtronic CRDM
Mounds View, MN 55112
Implementation of a software-related lead assembly process improvement, accommodating serial number variability.
P920015/S126
12/23/13
Sprint Quattro LeadMedtronic, Inc.
Mounds View MN, 55112
Update to the maximum sterilization load profile temperature for the devices.
P920047/S064
12/18/13
Blazer II, Blazer II HTD, and Blazer Prime HTD Ablation CathetersBoston Scientific Corporation
San Jose, CA
95134
Vendor manufacturing changes for the Blazer II, Blazer II HTD, Blazer Prime HTD, Blazer II XP, and Blazer Prime XP Ablation Catheters.
P930014/S072
12/30/13
Acrysof® Intraocular LensAlcon Laboratories, Inc.
Fort Worth, TX 76134
Change in cleaning operations of intraocular lenses.
P930031/S049
12/4/13
Wallstent (TIPS) Endoprosthesis with Unistep Plus Delivery SystemBoston Scientific Corporation
Maple Grove, MN 55311
Change to the inner member component manufacturing equipment.
P930031/S050
12/20/13
WALLSTENT® (TIPS) Endoprosthesis with Unistep Plus Delivery SystemBoston Scientific Corporation
Maple Grove, MN 55311
Eliminate an in-process verification activity.
P930031/S051
12/18/13
WALLSTENT® Tips Endoprosthesis with Unistep™ Plus Delivery SystemBoston Scientific
Maple Grove, MN 55311
Change to implement a LaserLinc Measurement System for measuring and sorting extruded components.
P930039/S097
12/12/13
CapSureFix LeadMedtronic CRDM
Mounds View, MN 55112
Implementation of a software-related lead assembly process improvement, accommodating serial number variability.
P930039/S100
12/23/13
Vitatron Crystalline LeadMedtronic, Inc.
Mounds View MN, 55112
Update to the maximum sterilization load profile temperature for the devices.
P940015/S030
12/5/13
SynviscGenzyme Corporation
Ridgefield, NJ 07657
Use of alternate equipment for filling syringes.
P940019/S042
12/20/13
WALLSTENT® (Iliac)  Endoprosthesis with Unistep Plus Delivery SystemBoston Scientific Corporation
Maple Grove, MN 55311
Eliminate an in-process verification activity.
P940019/S043
12/18/13
WALLSTENT® Iliac EndoprosthesisBoston Scientific
Maple Grove, MN 55311
Change to implement a LaserLinc Measurement System for measuring and sorting extruded components.
P950020/S066
12/18/13
Coronary Flextome® Cutting Balloon®Boston Scientific
Maple Grove, MN 55311
Change to implement a LaserLinc Measurement System for measuring and sorting extruded components.
P950024/S055
12/12/13
CapSure Epicardial Pacing LeadMedtronic CRDM
Mounds View, MN 55112
Implementation of a software-related lead assembly process improvement, accommodating serial number variability.
P950037/S129
12/3/13
Entovis DR, DR-T, SR-T and SR, Evia DR, DR-T, SR and SR-T, Estella DR, DR-T, SR-T and SR, Effecta DR, SR, D, S and Ecuro SR, SR-T, DR and DR-T PacemakersBiotronik, Inc.
Lake Oswego, OR 97035
Add two second tier component suppliers.
P950037/S130
12/3/13
Entovis DR, Entovis DR-T, Entovis SR-T, Evia DR, Evia DR-T, Evia SR, Evia SR-T, Entovis SR, Estella DR, Estella DR-T, Estella SR-T, Effecta DR, Effecta SR, Estella SR, Effecta D, Effecta S, Ecuro SR, Ecuro SR-T, Ecuro DR, Ecuro DR-TBiotronik, Inc.
Lake Oswego, OR 97035
Two new welding stations, copying existing processes from one workstation to another and minor process parameter changes.
P960004/S064
12/4/13
FINELINE II STEROX LeadsBoston Scientific Corporation
St. Paul, MN
55112
Removal of two redundant inspections at the manufacturing site for FINELINE II leads.
P960009/S186
12/13/13
Activa PC Implantable Neurostimulator, Activa SC Implantable Neurostimulators, Activa RC Implantable Neurostimulator, 1X4 Pocket Adaptor Kit, 2X4 Pocket Adaptor Kit, Kinetra Implantable NeurostimulatorMedtronic, Inc.
Minneapolis, MN 55432
Alternate Suppliers for 2 INS Silicone Components
P960011/S024
12/10/13
BVI 1% OVD (1% Sodium Hyaluronate Viscoelastic Surgical Aid Fluid)Ferring Pharmaceuticals, Incorporated
Parsippany, NJ 07504
Incorporate a change to a component in the manufacturing of the 1% Sodium Hyaluronate finished devices.
P960022/S010
12/11/13
SofLens Toric (alphafilcon A) Soft Contact LensesBausch & Lomb
Rochester, NY 14609
Change of UV curing light bulb.
P960040/S308
12/17/13
PUNCTUA ICDs;  TELIGEN ICDs; ENERGEN ICDs; INCEPTA ICDsBoston Scientific Corporation
St. Paul, MN
55112
Manufacturing changes to the high voltage capacitor for the devices.
P970004/S165
12/13/13
InterStim Implantable NeurostimulatorsMedtronic, Inc.
Minneapolis, MN 55432
Alternate Suppliers for 2 INS Silicone Components.
P970018/S029
12/13/13
BD PrepStain™ SystemBD Diagnostics
Women’s Health and Cancer
Durham, NC
27703
Removal of an in-process quality control (QC) test and a final release test associated with the manufacture of BD Density Reagent.
P970054/S010
12/23/13
Parvovirus B19 IgG Enzyme ImmunoassayDiaSorin Inc.
Stillwater, MN 55082
Change in a supplier of a component used in this assay.
P970055/S013
12/23/13
Parvovirus B19 IgM Enzyme ImmunoassayDiaSorin Inc.
Stillwater, MN 55082
Change in a supplier of a component used in this assay.
P980016/S446
12/16/13
Evera ICDsMedtronic, Inc.
Mounds View MN, 55112
A new laser welding station for the battery electrical connection process as well as a change in manufacturing location for the laser welding process and open circuit voltage inspection (OCV).
P980016/S447
12/12/13
EVERA Implantable Cardioverter DefibrillatorMedtronic CRDM
Mounds View, MN 55112
Software and hardware changes to the radio frequency test equipment.
P980016/S448
12/17/13
Evera S DR ICD; Evera S VR ICD; Evera XT DR ICD; Evera XT VR ICDMedtronic CRDM
Mounds View, MN 55112
Manufacture update to the 0.8 μm BiCMOS (Bipolar Complementary Metal Oxide Semiconductor) process flow at the IC supplier.
P980016/S449
12/12/13
Evera S DR, Evera S VR, Evera XT DR, and Evera XT VR ICD SystemsMedtronic CRDM
Mounds View, MN 55112
Change in manufacturing at the supplier to help center the distribution of the capacitance of the triple stack capacitor in order to improve yield.
P980016/S450
12/17/13
Evera S DR ICDs, Evera S VR ICDs, Evera XT DR ICDsMedtronic CRDM
Mounds View, MN 55112
Additional equipment for capacitor manufacturing at MECC to increase manufacturing capacity for the  devices.
P980022/S145
12/6/13
Guardian REAL-Time System, CGMS iPro System, iPro2 System, Paradigm REAL-Time System, and Paradigm REAL-Time Revel SystemMedtronic MiniMed
Northridge, CA 91325
In-process storage change to a nitrogen cabinet during manufacturing of the Sof-Sensor (Models: MMT-7002 C, D, E).
P980022/S148
12/5/13
Paradigm Real-Time System, Paradigm Real-Time Revel System and Guardian Real-Time CGM SystemMedtronic MiniMed, Inc.
Northridge, CA 91325
PC-Based Manufacturing Software update from Version 2.2A to Version 2.3A at the Medtronic MiniMed, Northridge facility, and update from Version 2.0D to Version 2.3A at the MPROC, Juncos facility for the Paradigm Real-Time Insulin Pump (Models: MMT-522, MMT-522k, MMT-722, and MMT-722k), the Paradigm Real-Time Revel Insulin Pump (Models: MMT-523, MMT-523k, MMT-723, and MMT-723k), the Guardian Real-Time Monitor (Model: CSS7100) and the MiniMed 530G Insulin Pump (Models MMT-551 and MMT-751).
P980024/S012
12/20/13
PathVysion HER-2 DNA Probe KitAbbott Molecular, Inc.
Des Plaines, IL 60018
Change to the fermentation stage of the UroVysion and PathVysion assay manufacturing processes.
P980033/S038
12/4/13
Wallstent (Venous) Endoprosthesis with Unistep Plus Delivery SystemBoston Scientific Corporation
Maple Grove, MN 55311
Change to the inner member component manufacturing equipment.
P980033/S039
12/20/13
WALLSTENT® (Venous) Endoprosthesis with Unistep Plus Delivery SystemBoston Scientific Corporation
Maple Grove, MN 55311
Eliminate an in-process verification activity.
P980033/S040
12/18/13
WALLSTENT® Venous Endoprosthesis with Unistep™ Plus RP Delivery System (10 mm Venous Endoprosthesis) and Unistep™ Plus Delivery System (12 mm - 16 mm Venous Endoprosthesis)Boston Scientific
Maple Grove, MN 55311
Change to implement a LaserLinc Measurement System for measuring and sorting extruded components.
P980035/S355
12/17/13
Advisa DR IPG; Advisa DR MRI IPGMedtronic CRDM
Mounds View, MN 55112
Manufacture update to the 0.8 μm BiCMOS (Bipolar Complementary Metal Oxide Semiconductor) process flow at the IC supplier.
P980040/S047
12/18/13
TECNIS® 1- Piece IOL TECNIS® OptiBlue 1-Piece IOL, TECNIS® Multifocal 3-Piece IOL, TECNIS® Multifocal 1- Piece IOL, TECNIS® Toric 1-Piece IOLAbbott Medical Optics Inc.
Santa Ana, CA 92705
Use of alternative degassing parameters.
P980050/S088
12/12/13
Transvene CS/SVC LeadMedtronic CRDM
Mounds View, MN 55112
Implementation of a software-related lead assembly process improvement, accommodating serial number variability.
P990009/S038
12/24/13
Floseal Hemostatic MatrixBaxter Healthcare Corporation
Round Lake, IL 60073
Change to the material of a component in the Floseal kit.
P990081/S024
12/16/13
PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary AntibodyVentana Medical Systems, Inc.
Tucson, AZ
85755
Addition of a new supplier for a PCBA used in the manufacture of the BenchMark XT Instrument.
P000007/S044
12/19/13
Edwards Prima Plus Stentless Porcine BioprosthesisEdwards Lifesciences, LLC
Irvine, CA
92614
Addition of Terminal Liquid Sterilization ovens No. 6 and No. 7.
P000040/S031
12/11/13
Genesys HTA SystemBoston Scientific Corporation
Marlborough, MA 01752
Replacement of a visual aid used in manufacturing with a vision system that will automate all aspects of the visual aid as well as inspect for the presence of additional components.
P010012/S343
12/6/13
EasyTrak 2, EasyTrak3, and Acuity Spiral LV LeadsBoston Scientific Corporation
St. Paul, MN
55112
Insourcing of heat bond processes for the subject left ventricular (LV) leads.
P010012/S344
12/17/13
PUNCTUA CRT-D;  COGNIS CRT-Ds; ENERGEN CRT-Ds;  INCEPTA CRT-DsBoston Scientific Corporation
St. Paul, MN
55112
Manufacturing changes to the high voltage capacitor for the devices.
P010014/S047
12/18/13
Oxford Meniscal Unicompartmental Knee SystemBiomet Manufacturing Corporation
Warsaw, IN
46582
Change to use an additional mill in the manufacturing of the femoral and tibial components of Biomet’s Oxford Partial Knee System.
P010019/S036
12/5/13
O2OPTIX, AIR OPTIX AQUA, AIR OPTIX for Astigmatism, AIR OPTIX AQUA MultifocalCIBA Vision Corporation
Duluth, GA
30097
Transition from a semi-automated to a fully automated manufacturing process.
P010029/S018
12/10/13
EUFLEXXA (1% Sodium Hyaluronate)Ferring Pharmaceuticals, Incorporated
Parsippany, NJ 07504
Incorporate a change to a component in the manufacturing of the 1% Sodium Hyaluronate finished devices.
P010030/S045
12/20/13
Lifevest Wearable Cardioverter DefibrillatorZoll Lifecor Corporation
Pittsburgh, PA 15238
Additional spot welder as well as updates to inspection instructions for the Lifevest Wearable Cardioverter Defibrillator.
P010030/S046
12/20/13
LifeVest 4000 Wearable Cardioverter DefibrillatorZoll Lifecor Corporation
Pittsburgh, PA 15238
Modification to the software installation process to use only the SD card utility to perform Flash Application loading.
P010031/S407
12/17/13
Brava, Viva S, and Viva XT CRT-D FamiliesMedtronic, Inc.
Mounds View MN, 55112
Modification to the battery header weld power range.
P010031/S408
12/16/13
Viva/Brava CRT-DsMedtronic, Inc.
Mounds View MN, 55112
A new laser welding station for the battery electrical connection process as well as a change in manufacturing location for the laser welding process and open circuit voltage inspection (OCV).
P010031/S409
12/12/13
VIVA Cardiac Resynchronization Therapy Defibrillator (CRT-D), BRAVA CRT-DMedtronic CRDM
Mounds View, MN 55112
Software and hardware changes to the radio frequency test equipment.
P010031/S410
12/17/13
Brava CRT-D; Viva S CRT-D; Viva XT CRT-DMedtronic CRDM
Mounds View, MN 55112
Manufacture update to the 0.8 μm BiCMOS (Bipolar Complementary Metal Oxide Semiconductor) process flow at the IC supplier.
P010031/S411
12/12/13
Brava, Viva S, and Viva XT CRT-D SystemsMedtronic CRDM
Mounds View, MN 55112
Change in manufacturing at the supplier to help center the distribution of the capacitance of the triple stack capacitor in order to improve yield.
P010031/S0412
12/17/13
Brava CRT-Ds, Viva S CRT-Ds, Viva XT CRT-DsMedtronic CRDM
Mounds View, MN 55112
Additional equipment for capacitor manufacturing at MECC to increase manufacturing capacity for the  devices.
P010041/S046
12/19/13
Carpentier-Edwards S.A.V. Aortic Porcine BioprosthesisEdwards Lifesciences, LLC
Irvine, CA
92614
Addition of Terminal Liquid Sterilization ovens No. 6 and No. 7.
P020009/S112
12/20/13
Express2 Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN 55311
Changes to the in-process endotoxin testing during component manufacturing.
P020009/S113
12/18/13
Express2™ Monorail® and OTW Coronary Stent SystemBoston Scientific
Maple Grove, MN 55311
Change to implement a LaserLinc Measurement System for measuring and sorting extruded components.
P020025/S050
12/3/13
Intella Tip MiFi XP Ablation CathetersBoston Scientific Corporation
San Jose, CA
95134
Change in the quality control (QC) inspections of the cardiac ablation system cables.
P020025/S051
12/18/13
Blazer II XP and Blazer Prime XP Ablation CathetersBoston Scientific Corporation
San Jose, CA
95134
Vendor manufacturing changes for the Blazer II, Blazer II HTD, Blazer Prime HTD, Blazer II XP, and Blazer Prime XP Ablation Catheters.
P020055/S012
12/16/13
PATHWAY Anti-c-KIT (9.7) Rabbit Monoclonal Primary AntibodyVentana Medical Systems, Inc.
Tucson, AZ
85755
Addition of a new supplier for a PCBA used in the manufacture of the BenchMark XT Instrument.
P030009/S070
12/12/13
Integrity Coronary Stent SystemsMedtronic Vascular
Santa Rosa, CA 95403
Consolidate and transfer extrusion activities to the Santa Rosa, CA facility.
P030009/S071
12/15/13
Integrity Rapid Exchange Coronary Stent SystemsMedtronic Vascular
Santa Rosa, CA 95403
Change to allow receiving inspection activities to be completed at Medtronic Mexico.
P030009/S072
12/19/13
Integrity Coronary Stent System (RX and OTW)Medtronic Vascular
Santa Rosa, CA 95403
Changes related to the software used in the measurement process of the waveforms at the ‘Wave Forming’ work step and the stents at the ‘Electro-Polish’ work step.
P030011/S022
12/13/13
SynCardia Temporary Total Artificial HeartSyncardia Systems, Inc.
Tucson, AZ 
85713
Change in the manufacturing site of the Internal Battery of the Companion 2 Driver System.
P030017/S182
12/4/13
Leads and Lead Extensions of the Precision and Precision Spectra Spinal Cord Stimulator SystemsBoston Scientific Neuromodulation
Valencia, CA
91355
Addition of an alternate supplier for a component of the Spinal Cord Stimulator System.
P030017/S183
12/10/13
Precision and Precision Spectra Spinal Cord Stimulator (SCS) SystemsBoston Scientific Corporation
Valencia, CA
91355
Boston Scientific Neuromodulation (BSN) Valencia facility to add the equipment and processes for multi-lumen tubes.
P030017/S184
12/13/13
Precision and Precision Spectra Spinal Cord Stimulator (SCS) SystemBoston Scientific Corporation
Valencia, CA
91355
Additional components for a sterilization process.
P030035/S114
12/4/13
Anthem, Anthem RFSt. Jude Medical, CRMD
Sylmar, CA
91342
Alternate Burn-In (BI) for the environmental screening during the manufacture of pacemaker and CRT-P hybrid assemblies.
P030036/S067
12/16/13
Selectsure LeadsMedtronic, Inc.
Mounds View MN, 55112
Transfer of incoming inspection to a new site for a number of components used in the manufacture of Medtronic CRDM therapy delivery products.
P030052/S014
12/20/13
UroVysion Bladder Cancer KitAbbott Molecular, Inc.
Des Plaines, IL 60018
Change to the fermentation stage of the UroVysion and PathVysion assay manufacturing processes.
P030054/S255
12/17/13
Promote, Promote Accel, Promote Q, Promote Quadra, Promote+, Quadra Assura, Unify, Unify Assura, and Unify Quadra Families of CRT-D DevicesSt. Jude Medical, CRMD
Sylmar, CA
91342
Alternate organic substrate manufacturer for use in the hybrid assemblies for the ICD and CRT-D devices.
P040016/S118
12/20/13
VeriFLEX (Liberté) Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN 55311
Changes to the in-process endotoxin testing during component manufacturing.
P040016/S119
12/18/13
VeriFLEX™ (Liberté®) Coronary Stent SystemBoston Scientific
Maple Grove, MN 55311
Change to implement a LaserLinc Measurement System for measuring and sorting extruded components.
P040020/S051
12/18/13
AcrySof IQ ReSTOR Intraocular lensesAlcon Laboratories, Inc.
Fort Worth, TX 76134
Manufacturing change to add an alternate quality test for manufacturing.
P040020/S053
12/30/13
Acrysof® Restor® Intraocular LensAlcon Laboratories, Inc.
Fort Worth, TX 76134
Change in cleaning operations of intraocular lenses.
P040047/S031
12/18/13
Coaptite Injectable ImplantMerz North America, Inc.
Franksville, WI 53126
Addition of an in-house endotoxin testing of the Coaptite product.
P040041/S032
12/20/13
Coaptite Injectable ImplantMerz North America, Inc.
Franksville, WI 53126
Movement of the manufacturing process of a critical component to a new facility.
P050023/S070
12/3/13
Lumax 340 VR-T (GB), 300 VR-T, 340VR-T, 500 VR-T (GB), 500 VR-T (Litronik), 540 VR-T DX, 300 DR-T, 340 DR-T, 500 DR-T ( GB), 500 DR-T (Litronik), 540 DR-T ICDs and Lumax 300 HF-T, 340 HF-T, 540 HF-T and 500 HF-T CRT-DsBiotronik, Inc.
Lake Oswego, OR 97035
Add two second tier component suppliers.
P050023/S071
12/3/13
Lumax 340 VR-T (GB), Lumax 300 VR-T, Lumax 340VR-T, Lumax 500 VR-T (GB), Lumax 500 VR-T (Litronik), Lumax 540 VR-T, Lumax 540 VR-T DX, Lumax 300 DR-T, Lumax 340 DR-T, Lumax 500 DR-T (GB), Lumax 500 DR-T (Litronik), Lumax 540 DR-T, Lumax 300 HF-T, Lumax 340 HF-T, Lumax 540 HF-T, Lumax 500 HF-TBiotronik, Inc.
Lake Oswego, OR 97035
Two new welding stations, copying existing processes from one workstation to another and minor process parameter changes.
P050037/S044
12/11/13
Radiesse Dermal FillerMerz North America, Inc.
Franksville, WI 53126
Process change to in house endotoxin testing.
P050037/S045
12/20/13
Radiesse Injectable Dermal FillerMerz North America, Inc.
Franksville, WI 53126
Change in packaging manufacturer facility.
P050046/S022
12/6/13
Acuity Steerable LV LeadBoston Scientific Corporation
St. Paul, MN
55112 
Insourcing of heat bond processes for the subject left ventricular (LV) leads.
P050048/S009
12/12/13
Bio-Rad MONOLISA™ Anti-HBs EIABio-Rad Laboratories, Inc.
Redmond, WA 98052
Change to add test samples as an additional acceptance criterion to the final kit release quality control testing procedure.
P050052/S047
12/11/13
Radiesse Dermal FillerMerz North America, Inc.
Franksville, WI 53126
Process change to in house endotoxin testing.
P050052/S048
12/20/13
Radiesse Injectable Dermal FillerMerz North America, Inc.
Franksville, WI 53126
Change in packaging manufacturer facility.
P060006/S051
12/20/13
Express SD Renal Monorail Premounted Stent SystemBoston Scientific Corporation
Maple Grove, MN 55311
Changes to the in-process endotoxin testing during component manufacturing.
P060006/S052
12/18/13
Express™ SD Renal Monorail® Premounted Stent SystemBoston Scientific
Maple Grove, MN 55311
Change to implement a LaserLinc Measurement System for measuring and sorting extruded components.
P060031/S007
12/12/13
Bio-Rad MONOLISA™ Anti-HBc EIABio-Rad Laboratories, Inc.
Redmond, WA 98052
Change to add test samples as an additional acceptance criterion to the final kit release quality control testing procedure.
P060033/S083
12/12/13
Endeavor Sprint Zotarolimus-Eluting Coronary Stent SystemMedtronic Vascular
Santa Rosa, CA 95403
Consolidate and transfer extrusion activities to the Santa Rosa, CA facility.
P060033/S084
12/15/13
Endeavor Sprint Zotarolimus-Eluting Coronary Stent SystemMedtronic Vascular
Santa Rosa, CA 95403
Change to allow receiving inspection activities to be completed at Medtronic Mexico.
P060034/S007
12/12/13
Bio-Rad MONOLISA™ Anti-HBc IgM EIABio-Rad Laboratories, Inc.
Redmond, WA 98052
Change to add test samples as an additional acceptance criterion to the final kit release quality control testing procedure.
P070008/S048
12/3/13
Stratos LV-T, Stratos LVBiotronik, Inc.
Lake Oswego, OR 97035
Two new welding stations, copying existing processes from one workstation to another and minor process parameter changes.
P080006/S061
12/16/13
Attain Ability LeadsMedtronic, Inc.
Mounds View MN, 55112
Transfer of incoming inspection to a new site for a number of components used in the manufacture of Medtronic CRDM therapy delivery products.
P080006/S062
12/18/13
Attain Ability LeadsMedtronic, Inc.
Mounds View MN, 55112
Update to the validated ranges of the elution and determination of related substances methods used in release testing Attain Ability leads.
P080010/S010
12/18/13
TECNIS® 1- Piece IOL TECNIS® OptiBlue 1-Piece IOL, TECNIS® Multifocal 3-Piece IOL, TECNIS® Multifocal 1- Piece IOL, TECNIS® Toric 1-Piece IOLAbbott Medical Optics Inc.
Santa Ana, CA 92705
Use of alternative degassing parameters.
P080014/S020
12/3/13
Cervista® HPV HRHologic Inc.
Marlborough, MA 01752
Increase of the manufacturing lot size for the Cleavase Enzyme Solution using manual filling with gravimetric confirmation.
P080015/S011
12/3/13
Cervista® HPV 16/18Hologic Inc.
Marlborough, MA 01752
Increase of the manufacturing lot size for the Cleavase Enzyme Solution using manual filling with gravimetric confirmation.
P080025/S061
12/13/13
InterStim Implantable NeurostimulatorsMedtronic, Inc.
Minneapolis, MN 55432
Alternate Suppliers for 2 INS Silicone Components
P080026/S011
12/11/13
Abbott RealTime HBVAbbott Molecular Inc.
Des Plaines, IL 60018
Manufacturing change conversion from a manual to an automated kit packaging system.
P080027/S015
12/17/13
OraQuick® HCV Rapid Antibody TestOraSure Technologies, Inc.
Bethelehem, PA 18015
Change to upgrade the OraQuick automation ultrasonic welding systems to improve the manufacturing process.
P080032/S014
12/2/13
The Alair Bronchial Thermoplasty SystemBoston Scientific Corporation
Marlborough, MA 01752
Change to the manufacturing of a cable connector, the addition of an inspection step and the elimination of a final acceptance activity.
P100017/S009
12/11/13
Abbott RealTime HCVAbbott Molecular Inc.
Des Plaines, IL 60018
Manufacturing change conversion from a manual to an automated kit packaging system.
P100021/S030
12/12/13
Endurant Stent Graft SystemMedtronic Vascular
Santa Rosa, CA 95403
Consolidate and transfer extrusion activities to the Santa Rosa, California facility.
P100023/S081
12/20/13
ION Paclitaxel-Eluting Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN 55311
Changes to the in-process endotoxin testing during component manufacturing.
P100023/S082
12/18/13
ION™ Paclitaxel- Eluting Coronary Stent System (Monorail and Over-The-Wire Systems)Boston Scientific
Maple Grove, MN 55311
Change to implement a LaserLinc Measurement System for measuring and sorting extruded components.
P100026/S001
12/18/13
NeuroPace RNS SystemNeuroPace, Inc.
Mountain View, CA 94043
Addition of a secondary component supplier.
P100026/S002
12/20/13
NeuroPace RNS SystemNeuroPace, Inc.
Mountain View, CA 94043
Re-implement a previously used laser welder as a backup welder.
P100027/S013
12/16/13
INFORM HER2 Dual ISH DNA Probe P020055/S012Ventana Medical Systems, Inc.
Tucson, AZ
85755
Addition of a new supplier for a PCBA used in the manufacture of the BenchMark XT Instrument.
P100033/S001
12/12/13
PROGENSA PCA3 AssayGen-Probe Incorporated
San Diego, CA 92121
Revised method for value assigning concentration of PSA Control B during manufacturing.
P100040/S014
12/12/13
Valiant Thoracic Stent Graft with the Captivia Delivery SystemMedtronic Vascular
Santa Rosa, CA 95403
Consolidate and transfer extrusion activities to the Santa Rosa, CA facility.
P100041/S046
12/19/13
Edwards SAPIEN Transcatheter Heart ValveEdwards Lifesciences, LLC
Irvine, CA
92614
Addition of Terminal Liquid Sterilization ovens No. 6 and No. 7.
P100044/S014
12/6/13
Propel and Propel Mini Sinus ImplantIntersect ENT
Menlo Park, CA 94025
Add an alternate material supplier.
P100049/S007
12/27/13
LINX Reflux Management SystemTorax Medical, Inc.
Shoreview, MN 55126
Changes to the firm’s cleaning machine, cleaning detergent, maximum bead load and cleaning temperature, and the addition of meshes during the cleaning and rinsing process.
P110002/S003
12/18/13
Mobi-C Cervical Disc Prosthesis (one-level indication)LDR Spine USA, Inc.
Austin, TX
78750
Tool change for the milling of the inferior endplate.
P110009/S003
12/18/13
Mobi-C Cervical Disc Prosthesis (two-level indication)LDR Spine USA, Inc.
Austin, TX
78750
Tool change for the milling of the inferior endplate.
P110010/S063
12/20/13
PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN 55311
Changes to the in-process endotoxin testing during component manufacturing.
P110010/S064
12/18/13
PROMUS® Element™ Plus Everolimus-Eluting Coronary Stent SystemBoston Scientific
Maple Grove, MN 55311
Change to implement a LaserLinc Measurement System for measuring and sorting extruded components.
P110011/S005
12/12/13
Assurant CobaltMedtronic Vascular
Santa Rosa, CA 95403
Consolidate and transfer extrusion activities to the Santa Rosa, California facility.
P110013/S029
12/12/13
Resolute Integrity Zotarolimus-Eluting Coronary Stent SystemsMedtronic Vascular
Santa Rosa, CA 95403
Consolidate and transfer extrusion activities to the Santa Rosa, California facility.
P110013/S030
12/15/13
Resolute Integrity Zotarolimus-Eluting Coronary Stent SystemMedtronic Vascular
Santa Rosa, CA 95403
Change to allow receiving inspection activities to be completed at Medtronic Mexico.
P110013/S031
12/19/13
Resolute Integrity Zotarolimus-Eluting Coronary Stent System (RX and OTW)Medtronic Vascular
Santa Rosa, CA 95403
Changes related to the software used in the measurement process of the waveforms at the ‘Wave Forming’ work step and the stents at the ‘Electro-Polish’ work step.
P110021/S033
12/19/13
Edwards SAPIEN Transcatheter Heart ValveEdwards Lifesciences, LLC
Irvine, CA
92614
Addition of Terminal Liquid Sterilization ovens No. 6 and No. 7.
P110033/S001
12/6/13
Juvederm Voluma XCAllergan
Goleta, CA
93117
Proposed addition of new sterilization equipment for use in Juvederm Voluma XC sterilization.
P110035/S024
12/18/13
Epic Vascular Self-Expanding Stent SystemBoston Scientific Corporation
Maple Grove, MN 55311
Removal of a redundant tensile test inspection and implementation of a new mold.
P110042/S021
12/3/13
Subcutaneous Implantable Defibrillator (S-ICD) SystemCameron Health, Inc.
San Clemente, CA 92673
Add a second supplier facility for performing laser welding and wetblast processes.
P110042/S022
12/12/13
Subcutaneous Implantable Defibrillator (S-ICD®) SystemCameron Health, Inc.
San Clemente, CA 92673
Add an additional glovebox to be used in manufacturing operations for the S-ICD System.
P110042/S023
12/16/13
Subcutaneous Implantable Defibrillator (S-ICD®) SystemCameron Health, Inc.
San Clemente, CA 92673
Additional laser spot weld system used in the manufacturing process for the S-ICD® System.
P110043/S004
12/20/13
Omnilink Elite Vascular Balloon-Expandable Stent SystemAbbott Vascular Inc.
Santa Clara, CA 95054
Change to the visual inspection process for the Omnilink Elite stent.
P120010/S006
12/5/13
MiniMed 530G SystemMedtronic MiniMed, Inc.
Northridge, CA 91325
PC-Based Manufacturing Software update from Version 2.2A to Version 2.3A at the Medtronic MiniMed, Northridge facility, and update from Version 2.0D to Version 2.3A at the MPROC, Juncos facility for the Paradigm Real-Time Insulin Pump (Models: MMT-522, MMT-522k, MMT-722, and MMT-722k), the Paradigm Real-Time Revel Insulin Pump (Models: MMT-523, MMT-523k, MMT-723, and MMT-723k), the Guardian Real-Time Monitor (Model: CSS7100) and the MiniMed 530G Insulin Pump (Models MMT-551 and MMT-751).

Summary of PMA Originals & Supplements Approved
Originals: 1
Supplements: 68

Summary of PMA Originals Under Review
Total Under Review: 54
Total Active: 23
Total On Hold: 31

Summary of PMA Supplements Under Review
Total Under Review: 579
Total Active: 389
Total On Hold: 190

Summary of All PMA Submissions Received
Originals: 5
Supplements: 65

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 68
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 185.8 
FDA Time: 141.6 Days  MFR Time: 44.2 Days

Page Last Updated: 06/25/2014
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