Medtech approvals: FDA releases December 2013 PMAs

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

PMA Original Approvals

APPLICATION NUMBER / DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION / INDICATIONS
P130006 12/5/13	GORE® VIABAHN® Endoprosthesis & GORE® VIABAHN® Endoprosthesis with Heparin BioActive Surface	W.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 APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION / INDICATIONS
N16837/S011 12/23/13 180-Day	Artegraft Bovine Collage Graft	Artegraft, 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 Adaptors	Medtronic, 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+ Lead	Medtronic, 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 lead	Medtronic, 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 Module	Thoratec 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) System	Thoratec 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 Lead	Medtronic, 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 Adaptors	Medtronic, 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 Lead	Medtronic, 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 ICDs	St. 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 Lead	Medtronic, 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 System	Boston 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 Lead	Medtronic, 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 Lead	Medtronic, 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 System	Advanced 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 Control	Medtronic 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 Batteries	Cochlear 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 System	Boston 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 ICD	Medtronic, 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 System	Medtronic 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 System	Medtrronic 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 IPG	Medtronic, 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 9995	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.
P980050/S081 12/24/13 180-Day	Transvene Lead	Medtronic, 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 System	Codman & 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 Graft	Medtronic 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 Device	Medtronic 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-P	Medtronic, 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-D	Medtronic, 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 System	Boston 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 System	Syncardia Systems, Inc. Tucson, AZ 85713	Approval of the post-approval study protocol.
P030036/S056 12/24/13 180-Day	Select Secure Lead	Medtronic, 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 System	InSightec, 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 System	Natus 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 Graft	Medtronic 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 Lead	Medtronic, 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 Implants	Sientra 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 System	DePuy 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 Lead	Medtronic, 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) Lead	Medtronic, Inc. Mounds View, MN 54112	Approval of the post-approval study protocol.
P080025/S052 12/11/13 135-Day	Interstim Therapy for Bowel Control	Medtronic 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 IPG	Medtronic, 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 Engine	VuCOMP, 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 Catheter	Medtronic 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 System	Medtronic Cryocath Quebec, Canada H9R 5Z8	Approval of the post-approval study protocol.
P100020/S012 12/16/13 Real-Time	cobas® HPV Test	Roche 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-HBc	Roche 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-HBc	Roche 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 System	HeartWare, 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 System	Torax 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 System	Medinol 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 System	Medtronic 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 Catheter	St. 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 System	Abbott 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 lgM	Roche 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 System	InSightec, 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 System	TriVascular, 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 System	TriVascular, 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 System	Medtronic 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 APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION / INDICATIONS
P780007/S052 12/13/13	Polymacon Extended Wear Contact Lenses	Coopervision Pleasanton, CA 94588	Manufacturing change to add a new quality test for manufacturing.
P810002/S088 12/19/13	St. Jude Mechanical Heart Valves	St. 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 System	DePuy 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 Lead	Medtronic 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 Kit	Medtronic, 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 Neurostimulator	Medtronic, 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 Pump	Medtronic 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 Bioprostheses	Edwards 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 Conduit	Edwards 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 System	Thoratec 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 Bioprostheses	Edwards 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 RF	St. 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 Lead	Medtronic CRDM Mounds View, MN 55112	Implementation of a software-related lead assembly process improvement, accommodating serial number variability.
P890003/S296 12/23/13	CapSure Lead	Medtronic, 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 Lenses	Coopervision Pleasanton, CA 94588	Manufacturing change to add a new quality test for manufacturing.
P900056/S129 12/15/13	Rotablator Rotational Atherectomy System	Boston 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 Lead	Medtronic, 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 Devices	St. 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 Lens	Bausch 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 Leads	Medtronic, 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 Lead	Medtronic 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 Lead	Medtronic, 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 Catheters	Boston 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 Lens	Alcon 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 System	Boston 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 System	Boston Scientific Corporation Maple Grove, MN 55311	Eliminate an in-process verification activity.
P930031/S051 12/18/13	WALLSTENT® Tips Endoprosthesis with Unistep™ Plus Delivery System	Boston Scientific Maple Grove, MN 55311	Change to implement a LaserLinc Measurement System for measuring and sorting extruded components.
P930039/S097 12/12/13	CapSureFix Lead	Medtronic 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 Lead	Medtronic, Inc. Mounds View MN, 55112	Update to the maximum sterilization load profile temperature for the devices.
P940015/S030 12/5/13	Synvisc	Genzyme Corporation Ridgefield, NJ 07657	Use of alternate equipment for filling syringes.
P940019/S042 12/20/13	WALLSTENT® (Iliac) Endoprosthesis with Unistep Plus Delivery System	Boston Scientific Corporation Maple Grove, MN 55311	Eliminate an in-process verification activity.
P940019/S043 12/18/13	WALLSTENT® Iliac Endoprosthesis	Boston 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 Lead	Medtronic 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 Pacemakers	Biotronik, 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-T	Biotronik, 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 Leads	Boston 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 Neurostimulator	Medtronic, 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 Lenses	Bausch & Lomb Rochester, NY 14609	Change of UV curing light bulb.
P960040/S308 12/17/13	PUNCTUA ICDs; TELIGEN ICDs; ENERGEN ICDs; INCEPTA ICDs	Boston Scientific Corporation St. Paul, MN 55112	Manufacturing changes to the high voltage capacitor for the devices.
P970004/S165 12/13/13	InterStim Implantable Neurostimulators	Medtronic, Inc. Minneapolis, MN 55432	Alternate Suppliers for 2 INS Silicone Components.
P970018/S029 12/13/13	BD PrepStain™ System	BD 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 Immunoassay	DiaSorin Inc. Stillwater, MN 55082	Change in a supplier of a component used in this assay.
P970055/S013 12/23/13	Parvovirus B19 IgM Enzyme Immunoassay	DiaSorin Inc. Stillwater, MN 55082	Change in a supplier of a component used in this assay.
P980016/S446 12/16/13	Evera ICDs	Medtronic, 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 Defibrillator	Medtronic 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 ICD	Medtronic 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 Systems	Medtronic 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 ICDs	Medtronic 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 System	Medtronic 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 System	Medtronic 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 Kit	Abbott 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 System	Boston 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 System	Boston 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 IPG	Medtronic 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 IOL	Abbott Medical Optics Inc. Santa Ana, CA 92705	Use of alternative degassing parameters.
P980050/S088 12/12/13	Transvene CS/SVC Lead	Medtronic 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 Matrix	Baxter 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 Antibody	Ventana 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 Bioprosthesis	Edwards Lifesciences, LLC Irvine, CA 92614	Addition of Terminal Liquid Sterilization ovens No. 6 and No. 7.
P000040/S031 12/11/13	Genesys HTA System	Boston 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 Leads	Boston 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-Ds	Boston 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 System	Biomet 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 Multifocal	CIBA 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 Defibrillator	Zoll 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 Defibrillator	Zoll 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 Families	Medtronic, Inc. Mounds View MN, 55112	Modification to the battery header weld power range.
P010031/S408 12/16/13	Viva/Brava CRT-Ds	Medtronic, 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-D	Medtronic 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-D	Medtronic 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 Systems	Medtronic 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-Ds	Medtronic 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 Bioprosthesis	Edwards Lifesciences, LLC Irvine, CA 92614	Addition of Terminal Liquid Sterilization ovens No. 6 and No. 7.
P020009/S112 12/20/13	Express2 Coronary Stent System	Boston 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 System	Boston 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 Catheters	Boston 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 Catheters	Boston 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 Antibody	Ventana 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 Systems	Medtronic 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 Systems	Medtronic 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 Heart	Syncardia 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 Systems	Boston 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) Systems	Boston 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) System	Boston Scientific Corporation Valencia, CA 91355	Additional components for a sterilization process.
P030035/S114 12/4/13	Anthem, Anthem RF	St. 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 Leads	Medtronic, 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 Kit	Abbott 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 Devices	St. 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 System	Boston 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 System	Boston 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 lenses	Alcon Laboratories, Inc. Fort Worth, TX 76134	Manufacturing change to add an alternate quality test for manufacturing.
P040020/S053 12/30/13	Acrysof® Restor® Intraocular Lens	Alcon Laboratories, Inc. Fort Worth, TX 76134	Change in cleaning operations of intraocular lenses.
P040047/S031 12/18/13	Coaptite Injectable Implant	Merz North America, Inc. Franksville, WI 53126	Addition of an in-house endotoxin testing of the Coaptite product.
P040041/S032 12/20/13	Coaptite Injectable Implant	Merz 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-Ds	Biotronik, 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-T	Biotronik, 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 Filler	Merz North America, Inc. Franksville, WI 53126	Process change to in house endotoxin testing.
P050037/S045 12/20/13	Radiesse Injectable Dermal Filler	Merz North America, Inc. Franksville, WI 53126	Change in packaging manufacturer facility.
P050046/S022 12/6/13	Acuity Steerable LV Lead	Boston 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 EIA	Bio-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 Filler	Merz North America, Inc. Franksville, WI 53126	Process change to in house endotoxin testing.
P050052/S048 12/20/13	Radiesse Injectable Dermal Filler	Merz North America, Inc. Franksville, WI 53126	Change in packaging manufacturer facility.
P060006/S051 12/20/13	Express SD Renal Monorail Premounted Stent System	Boston 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 System	Boston 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 EIA	Bio-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 System	Medtronic 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 System	Medtronic 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 EIA	Bio-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 LV	Biotronik, 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 Leads	Medtronic, 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 Leads	Medtronic, 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 IOL	Abbott Medical Optics Inc. Santa Ana, CA 92705	Use of alternative degassing parameters.
P080014/S020 12/3/13	Cervista® HPV HR	Hologic 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 16/18	Hologic 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 Neurostimulators	Medtronic, Inc. Minneapolis, MN 55432	Alternate Suppliers for 2 INS Silicone Components
P080026/S011 12/11/13	Abbott RealTime HBV	Abbott 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 Test	OraSure 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 System	Boston 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 HCV	Abbott 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 System	Medtronic 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 System	Boston 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 System	NeuroPace, Inc. Mountain View, CA 94043	Addition of a secondary component supplier.
P100026/S002 12/20/13	NeuroPace RNS System	NeuroPace, 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/S012	Ventana 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 Assay	Gen-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 System	Medtronic 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 Valve	Edwards 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 Implant	Intersect ENT Menlo Park, CA 94025	Add an alternate material supplier.
P100049/S007 12/27/13	LINX Reflux Management System	Torax 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 System	Boston 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 System	Boston Scientific Maple Grove, MN 55311	Change to implement a LaserLinc Measurement System for measuring and sorting extruded components.
P110011/S005 12/12/13	Assurant Cobalt	Medtronic 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 Systems	Medtronic 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 System	Medtronic 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 Valve	Edwards Lifesciences, LLC Irvine, CA 92614	Addition of Terminal Liquid Sterilization ovens No. 6 and No. 7.
P110033/S001 12/6/13	Juvederm Voluma XC	Allergan 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 System	Boston 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) System	Cameron 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®) System	Cameron 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®) System	Cameron 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 System	Abbott Vascular Inc. Santa Clara, CA 95054	Change to the visual inspection process for the Omnilink Elite stent.
P120010/S006 12/5/13	MiniMed 530G System	Medtronic 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).

Medtech approvals: FDA releases December 2013 PMAs

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