• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Medical Devices

  • Print
  • Share
  • E-mail

October 2011 PMA Approvals

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

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

PMA Original Approvals

APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
P090024
10/11/11
ADVIA Centaur HBeAg Assay and ADVIA Centaur HBeAg Quality Control MaterialSiemens Healthcare Diagnostics
Tarrytown, NY
10591
Approval for ADVIA Centaur HBeAg Assay & ADVIA Centaur HBeAg Quality Control Material. This device is indicated for:
ADVIA Centaur HBeAg Assay:
The ADVIA Centaur HBeAg assay is an in-vitro diagnostic immunoassay for the qualitative determination of the hepatitis B e antigen (HBeAg) in human serum and plasma (potassium EDTA, lithium or sodium heparin) from individuals who have signs and symptoms of hepatitis or who may be at risk for hepatitis B virus (HBV) infection using the ADVIA Centaur and ADVIA Centaur XP systems. This assay, in conjunction with other serological and clinical information, is intended only for the determination of chronic infection with hepatitis B virus.
ADVIA Centaur HBeAg Quality Control Material:
The controls are used for monitoring the performance of the HBeAg Assay on the ADVIA Centaur Systems. The performance of the HBeAg quality control material has not been established with any other HBeAg assay.
P100042
10/28/11
APTIMA HPV AssayGen-Probe Incorporated
San Diego, CA
92121
Approval for the APTIMA HPV Assay.
APTIMA HPV Assay Indications For Use:
The APTIMA HPV Assay is an in vitro nucleic acid amplification test for the qualitative detection Of E6/E7 viral messenger RNA (mRNA) from 14 high-risk types of human papillomavirus (HPV) in cervical specimens. The high-risk HPV types detected by the assay include: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. The APTIMA HPV Assay does not discriminate between the 14 high-risk types. Cervical specimens in ThinPrep Pap Test vials containing PreservCyt Solution and collected with broom-type or cytobrush/ spatula collection devices* may be tested with the APTIMA HPV Assay. The assay is used with the TIGRIS DTS System.
The use of the test is indicated:
1. To screen patients 21 years and older with atypical squamous cells of undetermined significance (ASC-US) cervical cytology results to determine the need for referral to
colposcopy. The results of this test are not intended to prevent women from proceeding to colposcopy. 2. In women 30 years and older, the APTIMA HPV Assay can be used with cervical cytology to adjunctively screen to assess the presence or absence of high-risk HPV types. This information, together with the physician's assessment of cytology history, other risk factors,
and professional guidelines, may be used to guide patient management.
* Broom-type device (e.g., Wallach Pipette) or endocervical brush/spatula.
P110011
10/26/11
Assurant® Cobalt Iliac Balloon-Expandable Stent SystemMedtronic Vascular
Santa Rosa, CA
95403
Approval for the Assurant® Cobalt Iliac Balloon-Expandable Stent System. This device is indicated for improving iliac luminal diameter in patients with de novo and restenotic lesions in the common and external iliac arteries, with reference vessel diameters between 6 mm and 10 mm and lesion lengths up to 61 mm. The stent is intended as a permanent implant.
P110022
10/26/11
Elecsys® Anti-HBc IgM Immunoassay and Elecsys® PreciControl Anti-HBc IgM for use on the cobas e 601 Immunoassay AnalyzerRoche Diagnostics
Indianapolis, IN
46250
Approval for the Elecsys® Anti-HBc IgM Immunoassay and Elecsys® PreciControl Anti-HBc IgM for use on the cobas e 601 Immunoassay Analyzer. This device is indicated for: Elecsys Anti-HBc IgM Immunoassay
The Elecsys Anti-HBc IgM Immunoassay is intended for the in vitro qualitative determination of IgM antibodies to hepatitis B core antigen (anti-HBc IgM) in human serum or plasma (potassium EDTA, lithium heparin, sodium heparin, sodium citrate). 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 IgM Immunoassay's performance has not been established for the monitoring of HBV disease or therapy.
The electrochemilu-minescence Immunoassay "ECLIA" is intended for use on the cobas e 601 immunoassay analyzer.
PreciControI Anti-HBc IgM
Elecsys PreciControl Anti-HBc IgM is used for quality control of the Elecsys Anti-HBc IgM Immunoassay on the cobas e 601 immunoassay analyzer.

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
P860003/S062
10/28/11
Special
THERAKOS CELLEX™ Photopheresis SystemTherakos, Inc.
Raritan, NJ
08869
Approval for a Technical Bulletin that will be sent out to users of the CELLEX™ system.
P880086/S210
10/14/11
180-Day
Sustain XL SC, DC, SR, DR PacemakersSt. Jude Medical
Sylmar, CA
91342
Approval for a manufacturing site located at St. Jude Medical Cardiac Rhythm Management Division in Penang, Malaysia.
P890070/S005
10/7/11
180-Day
Pure-Dent B851 Absorbable Dusting PowderGrain Processing Corporation
Muscatine, IA
52761
Approval for a manufacturing site located at PacMoore Process Technologies, LLC, in Mooresville, Indiana.
P910001/S049
10/25/11
Real-Time
CVX Excimer Laser SystemSpectranetics Corporation
Colorado Springs, CO
80921
Approval for software changes to the CVX-300 and CVX-300-P Laser Systems.
P910023/S240
10/20/11
Real-Time
Neutrino 2, Shiva, and Shiva 2 High Voltage CapacitorsSt. Jude Medical
Sylmar, CA
91342
Approval for Neutrino 2, Shiva, and Shiva 2 High Voltage Capacitors
P930014/S055
10/31/11
Real-Time
AcrySof® Intraocular Lens (IOL) and AcrySof® ReSTOR® IOLAlcon Research, LTD
Fort Worth, TX
76134
Approval for modifications to the AcrySof® Intraocular Lens (IOL) case (#79 and #80) drainage features.
P930014/S048
10/25/11
180-Day
Acrysof® Toric and Acrysof® IQ Toric High Cylinder Power IOLsAlcon Research, Ltd.
Fort Worth, TX
76134
Approval for post-approval study protocol.
P930038/S068
10/18/11
Real-Time
Angio-Seal™ Vascular Closure DeviceSt. Jude Medical
St. Paul, MN
55117
Approval to increase the Denaturation Temperature range to 42.41 – 53.3˚C.
P970003/S065
10/17/11
Real-Time
VNS Therapy SystemCyberonics, Inc.
Houston, TX
77058
Approval for labeling changes related to the use of MRI systems with the device.
P970003/S135
10/31/11
Real-Time
VNS Therapy System Demipulse GeneratorsCyberonics, Inc.
Houston, TX
77058
Approval for an upgrade to the Communication Flash Loader (CFL) portion of the firmware of the Demipulse Implantable Pulse Generators, Model 103 and Model 104.
P970020/S064
10/4/11
135-Day
MultiLink Zeta Coronary Stent SystemAbbott Vascular
Temecula, CA
92590
Approval for automation of the existing balloon necking process.
P970027/S015
10/7/11
Special
AxSYM Anti-HCVAbbott Laboratories
Abbott Park, IL
60064
Approval for a quality control test of an incoming raw material for the AxSYM Anti-HCV, ARCHITECT CORE-M and AxSYM CORE.
P970051/S085
10/4/11
Real-Time
Nucleus 24 Cochlear Implant SystemCochlear Americas
Centennial, CO
80111
Approval for a modified version of the Earhook attachment to the device, which involves a change in material.
P980016/S321
10/31/11
Real-Time
Entrust, Intrinsic, Marquis, Onyx, Secura, Gem, Maximo, Protecta and VirtuosoMedtronic, Inc.
Mounds View, MN
55112
Approval for an update to the life test specifications of high voltage capacitors.
P980022/S071
10/20/11
180-Day
iPro2 Professional Continuous Glucose Monitoring (CGM) SystemMedtronic MiniMed
Northridge, CA
91325
Approval for incorporating a USB connection for data upload, changing the operating time before recharging, changing to a web-based software system, and incorporating a docking station and cleaning plug. The device, as modified, will be marketed under the trade name iPro2 Professional Continuous Glucose Monitoring (CGM) System (MMT-7745).
P980022/S093
10/14/11
Real-Time
Continuous Glucose Monitoring SystemMedtronic MiniMed
Northridge, CA
91325
Approval for minor modifications to the pump case bottom cover to reduce the Rib (A) width dimensions, affecting the Paradigm Real-Time pump models MMT-722, MMT-722K, MMT-723 and MMT-723K.
P000032/S036
10/12/11
180-Day
Her Option Cryoablation Therapy SystemCooperSurgical, Inc. Trumbull, CT
06611
Approval for a manufacturing site located at CooperSurgical, Inc. in Trumbull, Conneticut.
P000058/S046
10/5/11
Real-Time
INFUSE® Bone Graft/L-T Cage Lumbar Tapered Fusion DeviceMedtronic Sofamor Danek
Memphis, TN
31832
Approval for replacing the Plastisol caps used to hold the fusion cage component with polyethylene bags.
P010029/S008
10/11/11
Panel-Track
EUFLEXXA®Ferring Pharmaceuticals, Inc.
Parsippany, NJ
07054
Approval for EUFLEXXA ® (1 % sodium hyaluronate). This device is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and to simple analgesics (e.g., acetaminophen).
P010031/S275
10/31/11
Real-Time
Consulta, Maximo II, Concerto, InsyncMedtronic, Inc.
Mounds View, MN
55112
Approval for an update to the life test specifications of high voltage capacitors.
P010032/S041
10/28/11
Real-Time
Genesis and Eon Family Neurostimulation (IPG) SystemsSt. Jude Medical
Plano, TX
75024
Approval for a modification to the amplitude button of the patient programmer that added material to prevent off-center actuations.
P010033/S019
10/20/11
Special
QuantiFERON® TB GoldCellestis, Incorporated
Valencia, CA
91355
Approval for changes to the labeling: Instructions for Use section, Specimen Collection and Handling section, and Abbreviated Test Procedure section for use of the QuantiFERON® Blood Collection tubes.
P020041/S002
10/13/11
180-Day
FemCapFemCap, Inc.
Del Mar, CA
92014
Approval for a manufacturing site located at Helix Medical, LLC. in Carpinteria, CA
93013
P020047/S035
10/4/11
135-Day
Vision and ML8 Coronary Stent SystemsAbbott Vascular
Temecula, CA
92590
Approval for automation of the existing balloon necking process.
P030017/S119
10/21/11
180-Day
Precision® Spinal Cord Stimulation (SCS) SystemBoston Scientific Neuromodulation Valencia, CA
91355
Approval for the Infinion 1x16 Percutaneous Lead and 2x8 Splitter.
P030022/S017
10/14/11
135-Day
REFLECTION Ceramic Acetabular Hip System (RCHS) and BIRMINGHAM HIP Resurfacing System (BHR)Smith & Nephew, Inc.
Memphis, TN
38116
Approval for the addition of an alternative site for the porous coating process for the R3 Acetabular Shells.
P030054/S159
10/20/11
Real-Time
Neutrino 2, Shiva, and Shiva 2 High Voltage CapacitorsSt. Jude Medical, Inc.
Sylmar, CA
91342
Approval for the Neutrino 2, Shiva, and Shiva 2 High Voltage Capacitors.
P030054/S200
10/20/11
Real-Time
Merlin Patient Care SystemSt. Jude Medical, Inc.
Sylmar, CA
91342
Approval for changes to the internal components of the device.
P040020/S036
10/31/11
Real-Time
AcrySof® Intraocular Lens (IOL) and AcrySof® ReSTOR® IOLAlcon Research, LTD
Fort Worth, TX
76134
Approval for modifications to the AcrySof® Intraocular Lens (IOL) case (#79 and #80) drainage features.
P040021/S018
10/13/11
135-Day
Biocor & Epic ValvesSt. Jude Medical, Inc.
St. Paul, MN
55117
Approval for a change in the jar set assembly packaging and ethylene oxide sterilization load configuration.
P040024/S051
10/11/11
Panel-Track
Restylane Injectable GelMedicis Aesthetics, Inc.
Scottsdale, AZ
85256
Approval for Restylane Injectable Gel. This device is indicated for: 1) mid-to-deep dermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds; and 2) submucosal implantation for lip augmentation in patients over the age of 21.
P040033/S017
10/14/11
135-Day
REFLECTION Ceramic Acetabular Hip System (RCHS) and BIRMINGHAM HIP Resurfacing System (BHR)Smith & Nephew, Inc.
Memphis, TN
38116
Approval for the addition of an alternative site for the porous coating process for the R3 Acetabular Shells.
P040037/S036
10/27/11
135-Day
VIABAHN EndoprosthesisW.L. Gore & Associates, Inc.
Flagstaff, AZ
86001
Approval for an alternate supplier of the drug coating component of the device.
P040044/S034
10/4/11
180-Day
Mynx™ with Grip Technology™Access Closure
Mountain View, CA
94043
Approval for a modified version of the Mynx Vascular Closure Device called the Mynx™ Vascular Closure Device with Grip Technology™.
P050006/S020
10/13/11
135-Day
GORE HELEX Septal OccluderW.L. Gore & Associates, Inc.
Flagstaff, AZ
86001
Approval to modify an acceptance criterion for the control catheter component.
P050010/S009
10/4/11
135-Day
ProDisc™ Total Disc ReplacementSynthes Spine
West Chester, PA
19380
Approval for a change from a manual polishing process to an automated polishing process and the addition of a passivation process after the plasma coating process.
P050037/S024
10/31/11
180-Day
RadiesseMerz Aesthetics, Inc.
Franksville, WI
53126
Approval for a new product fill volume (i.e., 3.0cc).
P050052/S027
10/31/11
180-Day
RadiesseMerz Aesthetics, Inc.
Franksville, WI
53126
Approval for a new product fill volume (i.e., 3.0cc).
P060012/S008
10/7/11
Special
AxSYM COREAbbott Laboratories
Abbott Park, IL
60064
Approval for a quality control test of an incoming raw material for the AxSYM Anti-HCV, ARCHITECT CORE-M and AxSYM CORE.
P060022/S010
10/21/11
180-Day
Akreos Posterior Chamber Intraocular Lens (IOL)Bausch & Lomb, Inc.
Aliso Viejo, CA
92656
Approval for the removal of verbiage pertaining to the clinical assessment of the addition of the aspheric surface.
P060033/S066
10/25/11
135-Day
Endeavor Sprint Zotarlimus-Eluting Coronary Stent SystemsMedtronic Vascular, Inc.
Santa Rosa, CA
95403
Approval for a change to the drug spray in-process controls.
P060035/S010
10/7/11
Special
ARCHITECT CORE-MAbbott Laboratories
Abbott Park, IL
60064
Approval for a quality control test of an incoming raw material for the AxSYM Anti-HCV, ARCHITECT CORE-M and AxSYM CORE.
P070014/S023
10/27/11
180-Day
LifeStent Vascular Stent SystemBard Peripheral Vascular, Inc.
Tempe, AZ
85281
Approval for a manufacturing site located at Angiomed GmbH & Co. in Karlsruhe, Germany.
P070014/S026
10/26/11
Special
Bard LifeStent SOLO Vascular Stent SystemBard Peripheral Vascular, Inc.
Tempe, AZ
85281
Approval for modifications to the product labeling, predominantly with respect to improving the safe use of the device by modifying the stent deployment procedure language in the Instructions for Use, as well as adding new symbols to the labeling.
P070015/S072
10/4/11
135-Day
XIENCE V and PROMUS Everolimus-Eluting Coronary Stent SystemAbbott Vascular
Temecula, CA
92590
Approval for automation of the existing balloon necking process.
P080025/S021
10/11/11
180-Day
InterStim Sacral Nerve Stimulation Therapy for Bowel ControlMedtronic, Inc.
Minneapolis, MN
55432
Approval of post-approval protocol.
P080027/S003
10/20/11
135-Day
OraQuick® Rapid HCV Antibody TestOraSure Technologies, Inc.
Bethlehem, PA
18015
Approval for hold time extensions for raw material, components and in-process material for the manufacturing of the device.
P090018/S013
10/28/11
Real-Time
Esteem®Envoy Medical Corporation
Saint Paul, MN
55110
Approval for user interface firmware changes to the Esteem Personal Programmer.
P100014//S004
10/27/11
180-Day
Solesta Injectable Bulking AgentOcean Therapeutics, Inc.
Edison, NJ
08817
Approval of the post-approval protocol.
P100023/S002
10/25/11
135-Day
ION (Taxus Element) Paclitaxel-Eluting Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Approval for changes to In-Process Monitoring (IPM) requirements.
P100027/S001
10/13/11
Real-Time
INFORM HER2 Dual ISH DNA Probe CocktailVentana Medical Systems, Inc.
Tucson, AZ
85755
Approval for modification of the stability testing protocol to allow for extension of the shelf life of the device from
6 months to 18 months.
P100029/S004
10/13/11
135-Day
Trifecta ValveSt. Jude Medical, Inc.
St. Paul, MN
55117
Approval for a change in the jar set assembly packaging and ethylene oxide sterilization load configuration.

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

APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
D970012/S089
10/26/11
AMS Model 700 Inflatable Penile ProsthesisAmerican Medical Systems
Minnetonka, MN
55343
Change in the packaging process for the devices.
P780007/S046
10/21/11
Biomedics 38 (Polymacon) Soft (Hydrophilic) Contract LensesCooperVision Incorporated
Pleasanton, CA
94588
Addition of sterilization cycle runs for single blisters, CVI blisters and six pack blisters to sterilizer Fedegari.
P840001/S196
10/21/11
Restore Family of Implantable NeurostimulatorsMedtronic, Inc.
Minneapolis, MN
55432
Implement software updates to the Self Test application of the Next Generation Tester.
P850068/S009
10/14/11
Bausch & Lomb Silsoft (elastofilcon A) Contact LensesBausch & Lomb Incorporated
Rochester, NY
14609
Change the manufacturing process of the optical tools used to manufacture the device.
P870025/S010
10/12/11
Fetal Acoustic Stimulator (FAST)Wipro GE Healthcare
Laurel, MD
20723
Changes to the suppliers for components of the FAST device.
P890003/S236
10/21/11
ProdigyMedtronic, Inc.
Mounds View, MN
55112
Change to upgrade the software version from 1.5.1 to 1.5.2 on a laser welder at a supplier.
P910023/S274
10/7/11
Fortify ICDsSt. Jude Medical
Sylmar, CA
91392
Changes to the limits for a device level manufacturing test as well as the addition of in-process verification tests.
P910023/S275
10/12/11
Fortify ICDsSt. Jude Medical
Sylmar, CA
91392
Use of an alternate supplier for back-up bands.
P940015/S022
10/7/11
Synvisc® and Synvisc-One®Genzyme Corporation
Cambridge, MA
02142
Addition of a syringe assembly machine to the packaging department.
P940015/S023
10/7/11
Synvisc® and Synvisc-One®Genzyme Corporation
Cambridge, MA
02142
Addition of a raw material identification system and an automated filter integrity test instrument.
P950005/S035
10/7/11
Celsius, Celsius RMT, EZ Steer, EZ Steer DS, Non-Temperature Sensing Ablation Catheters and Interface CablesBiosense Webster, Inc.
Diamond Bar, CA
91765
Parametric release of sterilized product using ethylene oxide.
P960009/S127
10/21/11
Activa Family of Implantable NeurostimulatorsMedtronic, Inc.
Minneapolis, MN
55432
Implement software updates to the Self Test application of the Next Generation Tester.
P960013/S067
10/6/11
Tendril Family of LeadsSt Jude Medical, Inc.
Sylmar, CA
91342
Increase the length of the ring electrode masking.
P960040/S246
10/26/11
Cognis CRT-DsBoston Scientific Corporation
St. Paul, MN
55112
Alternate supplier of ceramic capacitor used for pulse generator (PG) manufacturing.
P960058/S092
10/26/11
Harmony HiResolution Bionic Ear SystemAdvanced Bionics Corporation
Sylmar, CA
91342
Change in the manufacturing process to improve an insertion tool and to document a change in the tool suppliers.
P970003/S136
10/18/11
VNS Therapy® Pulse GeneratorsCyberonics, Inc.
Houston, TX
77058
Change to inventory control and traceability of components and subassemblies.
P970003/S137
10/21/11
VNS Therapy® SystemCyberonics, Inc.
Houston, TX
77058
Change in the acceptance criteria for the Model 102/102R Pulse Generators.
P970003/S138
10/27/11
VNS Therapy® SystemCyberonics, Inc.
Houston, TX
77058
Implementation of Statistical Process Control (SPC) software.
P970008/S059
10/26/11
Urologix Targis System for the Treatment of BPHUrologix, Inc.
Minneapolis, MN
55447
Change in adhesive in the manufacturing of the Urologix Targis System control units.
P970020/S069
10/28/11
Multi-Link Zeta and Ultra Coronary Stent SystemsAbbott Vascular, Inc.
Temecula, CA
92591
Automated process for preparation of the adaption cup.
P970027/S016
10/19/11
AxSYM Anti HCVAbbott Laboratories
Abbott Park, IL
60064
Relocation of a formulation room for the lyophilization of alkaline-treated casein used in the device.
P980016/S322
10/13/11
EnTrust, Intrinsic, Marquis, Maximo, Maximo II, Protecta, Protecta XT,
Secura, Virtuoso, and Virtuoso II ICDs
Medtronic, Inc.
Mounds View, MN
55112
Software updates for a testing application.
P980035/S241
10/13/11
Adapta, Advisa, EnRhythm, Relia, Sensia, and Versa IPGsMedtronic, Inc.
Mounds View, MN
55112
Software updates for a testing application.
P980035/S243
10/21/11
350 Series, Adapta, EnPulse, EnRhythm, Relia, Sensia, Sigma and VersaMedtronic, Inc.
Mounds View, MN
55112
Change to upgrade the software version from 1.5.1 to 1.5.2 on a laser welder at a supplier.
P990001/S095
10/13/11
Vitatron DA+ C-Series and Vitatron DA+ T-Series IPGsMedtronic, Inc.
Mounds View, MN
55112
Software updates for a testing application.
P990001/S097
10/21/11
Vitatron DA+ C-Series IPGMedtronic, Inc.
Mounds View, MN
55112
Change to upgrade the software version from 1.5.1 to 1.5.2 on a laser welder at a supplier.
P990025/S029
10/7/11
NaviStar, NaviStar RMT, EZ Steer Nav, QwikStar Catheters and Interface CablesBiosense Webster, Inc.
Diamond Bar, CA
91765
Parametric release of sterilized product using ethylene oxide.
P990071/S015
10/7/11
Interface CablesBiosense Webster, Inc.
Diamond Bar, CA
91765
Parametric release of sterilized product using ethylene oxide.
P000010/S025
10/11/11
AMPLICOR HCV Test, v2.0Roche Molecular Systems, Inc.
Pleasanton, CA
94588
Changes to the room location and equipment for filling and labeling of certain vialed intermediate components.
P000012/S035
10/11/11
COBAS AMPLICOR HCV Test, v2.0 and COBAS AmpliPrep/ COBAS AMPLICOR HCV Test, v2.0Roche Molecular Systems, Inc.
Pleasanton, CA
94588
Changes to the room location and equipment for filling and labeling of certain vialed intermediate components.
P000039/S042
10/21/11
AMPLATZER Septal Occluder AMPLATZER 45 Delivery and Exchange SystemsAGA Medical Corporation
Plymouth, MN
55442
Change the current seal test method from manual to semiautomatic.
P000040/S019
10/3/11
HTA System ProCerva Procedure SetBoston Scientific Corporation
Marlborough, MA
01752
Addition of a new manufacturing fixture and the modifications of an existing manufacturing fixture.
P000053/S039
10/26/11
AMS 800 Urinary Control SystemAmerican Medical Systems
Minnetonka, MN
55343
Change in the packaging process for the devices.
P010012/S272
10/26/11
Teligen ICDsBoston Scientific Corporation
St. Paul, MN
55112
Alternate supplier of ceramic capacitor used for pulse generator (PG) manufacturing.
P010015/S138
10/13/11
Consulta and Syncra CRT-PsMedtronic, Inc.
Mounds View, MN
55112
Software updates for a testing application.
P010015/S140
10/21/11
InSync IIIMedtronic, Inc.
Mounds View, MN
55112
Change to upgrade the software version from 1.5.1 to 1.5.2 on a laser welder at a supplier.
P010019/S026
10/28/11
Lotrafilcon A and Lotrafilcon B Soft Contact Lenses for Extended WearCIBA VISION Corporation
Duluth, GA
30097
Addition of an alternate supplier for Isopropyl Alcohol (IPA).
P010020/S021
10/26/11
Acticon NeosphincterAmerican Medical Systems
Minnetonka, MN
55343
Change in the packaging process for the devices.
P010030/S030
10/26/11
LifeVest Wearable Cardioverter DefibrillatorZOLL Lifecor Corporation
Pittsburgh, PA
15238
Alternate supplier for the holster and a change to the incoming inspection sampling plan.
P010031/S276
10/13/11
Concerto, Concerto II, Consulta, InSync II Marquis, InSync III Marquis,
InSync Maximo, InSync Sentry, Maximo II, Protecta, and Protecta XT
ICDs
Medtronic, Inc.
Mounds View, MN
55112
Software updates for a testing application.
P010047/S013
10/19/11
ProGel™ Pleural Air Leak SealantNeomend, Inc.
Irvine, CA
92618
Reduction in sample size of the current testing for the applicator kits.
P010068/S025
10/7/11
Celsius DS, NaviStar DS, NaviStar RMT DS, EZ Steer Nav DS, QwikStar DS Catheters and Interface CablesBiosense Webster, Inc.
Diamond Bar, CA
91765
Parametric release of sterilized product using ethylene oxide.
P020004/S065
10/24/11
GORE EXCLUDER AAA EndoprosthesisW.L. Gore & Associates, Inc.
Flagstaff, AZ
86001
Change to visual inspection criteria for the stent graft deployment line fiber.
P020004/S066
10/27/11
GORE EXCLUDER AAA EndoprosthesisW.L. Gore & Associates, Inc.
Flagstaff, AZ
86001
Update in bacterial endotoxin testing software.
P020009/S078
10/19/11
Express and Express 2 Coronary Stent SystemsBoston Scientific Corporation
Maple Grove, MN
55311
Additional sterilization cycle for the device.
P020009/S079
10/31/11
Express Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Process settings to be optimized or defined for extrusion of the proximal outer component.
P020024/S034
10/21/11
AMAPLATZER Duct Occluder 180 Delivery and Exchange SystemAGA Medical Corporation
Plymouth, MN
55442
Change the current seal test method from manual to semiautomatic.
P020045/S040
10/7/11
Freezor Cardiac CryoAblation Catheter, Freezor Xtra Surgical and Freezor MAX Surgical CryoAblation DevicesMedtronic CryoCath LP
Pointe Claire, Quebec
H9R5Z8
Change to reduce adhesive curing time for ECG rings and the tip electrode.
P020047/S040
10/28/11
Multi-Link Vision, Multi-Link Mini Vision, ML8 Coronary Stent SystemsAbbott Vascular, Inc.
Temecula, CA
92591
Automated process for preparation of the adaption cup.
P020052/S008
10/13/11
Response™ CV Cardioversion Electrophysiology Catheter and System Accessory EquipmentSt. Jude Medical, Inc.
Minnetonka, MN
55345
Eliminate the UV Post Trim process.
P030009/S060
10/19/11
Driver OTW Stent SystemMedtronic, Inc.
Santa Rosa, CA
95403
Changing the product print information from a manual process to an automated process.
P030017/S123
10/12/11
Precision® Spinal Cord Stimulator SystemBoston Scientific Neuromodulation
Valencia, CA
91355
Add an alternative welder for the antenna welding process.
P030031/S035
10/7/11
Celsius ThermoCool, Celsius RMT ThermoCool, NaviStar ThermoCool, NaviStar RMT ThermoCool, EZ Steer ThermoCool and EZ Steer ThermoCool Nav CathetersBiosense Webster, Inc.
Diamond Bar, CA
91765
Parametric release of sterilized product using ethylene oxide.
P030032/S013
10/7/11
PREVELLE SilkGenzyme Corporation
Cambridge, MA
02142
Addition of a raw material identification system and an automated filter integrity test instrument.
P030054/S201
10/7/11
Unify CRT-DsSt. Jude Medical
Sylmar, CA
91392
Changes to the limits for a device level manufacturing test as well as the addition of in-process verification tests.
P030054/S203
10/12/11
Unify CRT-DsSt. Jude Medical
Sylmar, CA
91392
Use of an alternate supplier for back-up bands.
P040016/S078
10/14/11
VeriFLEX (Liberté) Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Implementation of a semi-automated kitting process of accessory kits at a contract supplier.
P040016/S079
10/19/11
VeriFLEX OTW Bare Metal Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Updates to the Hydrophilic Coating (HPC) equipment process.
P040016/S080
10/31/11
VeriFLEX Coronary Stent System (Formerly Liberté)Boston Scientific Corporation
Maple Grove, MN
55311
Process settings to be optimized or defined for extrusion of the proximal outer component.
P040016/S081
10/31/11
VeriFLEX (Liberté) Bare Metal Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Hardware and software updates for the Plasma Treater.
P040020/S038
10/6/11
AcrySof Intraocular Lenses (IOLs)Alcon Research, Ltd.
Fort Worth, TX
76134
Modifications to the final cleaning process.
P040027/S025
10/27/11
GORE VIATORR TIPS EndoprosthesisW.L. Gore & Associates, Inc.
Flagstaff, AZ
86001
Final product assembly at the firm’s Phoenix location.
P040027/S026
10/27/11
GORE VIATORR TIPS EndoprosthesisW.L. Gore & Associates, Inc.
Flagstaff, AZ
86001
Update in bacterial endotoxin testing software.
P040036/S026
10/7/11
NaviStar ThermoCool, NaviStar RMT ThermoCool, EZ Steer ThermoCool and EZ Steer ThermoCool Nav CathetersBiosense Webster, Inc.
Diamond Bar, CA
91765
Parametric release of sterilized product using ethylene oxide.
P040037/S038
10/27/11
GORE VIABAHN EndoprosthesisW.L. Gore & Associates, Inc.
Flagstaff, AZ
86001
Update in bacterial endotoxin testing software.
P040040/S019
10/21/11
AMPLATZER Muscular VSD OccluderAGA Medical Corporation
Plymouth, MN
55442
Change the current seal test method from manual to semiautomatic.
P040043/S042
10/24/11
GORE TAG Thoracic EndoprosthesisW.L. Gore & Associates, Inc.
Flagstaff, AZ
86001
Change to visual inspection criteria for the stent graft deployment line fiber.
P040043/S043
10/27/11
GORE TAG THORACIC EndoprosthesisW.L. Gore & Associates, Inc.
Flagstaff, AZ
86001
Update in bacterial endotoxin testing software.
P040045/S025
10/12/11
VISTAKON (senofilcon A) Brand Contact LensesJohnson & Johnson Vision Care, Inc.
Jacksonville, FL
32256
Upgrade to the saline dose head during the manufacturing of the device.
P040045/S027
10/26/11
Vistakon (senofilcon A) Contact Lenses, Clear & Visibly Tinted with UV BlockerJohnson & Johnson Vision Care, Inc.
Jacksonville, FL
32256
Update the current test method for Vistakon (senofilcon A) Contact Lenses.
P050006/S021
10/21/11
GORE HELEX Septal OccluderW.L. Gore & Associates, Inc.
Flagstaff, AZ
86001
Replacement of sand paper with a lock loop polishing tool in the manufacture of the subject device.
P050006/S022
10/27/11
GORE HELEX Septal OccluderW.L. Gore & Associates, Inc.
Flagstaff, AZ
86001
Addition of a procedure for inventory processing.
P050006/S023
10/19/11
GORE HELEX Septal OccluderW.L. Gore & Associates, Inc.
Flagstaff, AX
86001
Addition of Expiry Report requirement to the return product procedure.
P050006/S024
10/27/11
GORE HELEX Septal OccluderW.L. Gore & Associates, Inc.
Flagstaff, AZ
86001
Update in bacterial endotoxin testing software.
P050006/S026
10/28/11
GORE HELEX Septal OccluderW.L. Gore & Associates, Inc.
Flagstaff, AZ
86001
Adoption of an instruction for single piece flow in the boxing operation.
P050018/S015
10/27/11
AngioSculpt PTCA Scoring Balloon CatheterAngioscore, Inc.
Fremont, CA
94538
Remove redundant in-process inspection tests.
P050028/S022
10/11/11
COBAS TaqMan HBV Test For Use with The High Pure System and COBAS AmpliPrep/COBAS TaqMan HBV Test v2.0Roche Molecular Systems, Inc.
Pleasanton, CA
94588
Changes to the room location and equipment for filling and labeling of certain vialed intermediate components.
P060002/S021
10/31/11
Bard Flair Endovascular Stent GraftC.R. Bard, Inc.
Tempe, AZ
85281
Introduction of an automated labeling inspection system and introduction of a new barcode scan system.
P060003/S010
10/3/11
Abbott AxSYM AUSABAbbott Laboratories Abbott Park, IL
60064
Change to vendor for the incoming Non-Fat Dry Milk.
P060008/S077
10/14/11
TAXUS Liberté Paclitaxel-Eluting Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Implementation of a semi-automated kitting process of accessory kits at a contract supplier.
P060008/S078
10/14/11
TAXUS Liberté Paclitaxel-Eluting Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Change to the feedstock source for the manufacturing of a solvent.
P060008/S079
10/19/11
TAXUS Liberté OTW Paclitaxel-Eluting Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Updates to the Hydrophilic Coating (HPC) equipment process.
P060008/S080
10/31/11
TAXUS Liberté Paclitaxel-Eluting Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Process settings to be optimized or defined for extrusion of the proximal outer component.
P060008/S081
10/31/11
TAXUS Liberté Paclitaxel-Eluting Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Hardware and software updates for the Plasma Treater.
P060022/S009
10/7/11
Akreos Posterior Chamber Intraocular LensesBausch & Lomb, Inc.
Aliso Viejo, CA
92656
Transfer of bioburden testing of the Akreos Adapt AO Holder Folder, M160 Holder, and Parker Gasket from a contract vendor to Bausch & Lomb.
P060030/S023
10/11/11
COBAS AmpliPrep/ COBAS TaqMan HCV TestRoche Molecular Systems, Inc.
Pleasanton, CA
94588
Changes to the room location and equipment for filling and labeling of certain vialed intermediate components.
P060033/S068
10/19/11
Endeavor Sprint Zotarolimus-Eluting Coronary Stent SystemMedtronic, Inc.
Santa Rosa, CA
95403
Changing the product print information from a manual process to an automated process.
P070007/S032
10/19/11
Talent Thoracic Stent Graft with Xcelerant Delivery SystemMedtronic Vascular
Santa Rosa, CA
95403
Modification of a wiping procedure.
P070014/S024
10/7/11
LifeStent Vascular Stent SystemsBard Peripheral Vascular, Inc.
Tempe, AZ
85281
Change to the tensile testing process.
P070014/S028
10/31/11
LifeStent Vascular StentC.R. Bard, Inc.
Tempe, AZ
85281
Introduction of an automated labeling inspection system and introduction of a new barcode scan system.
P070015/S081
10/28/11
XIENCE V and PROMUS Everolimus-Eluting Coronary StentAbbott Vascular, Inc.
Temecula, CA
92591
Automated process for preparation of the adaption cup.
P070027/S033
10/19/11
Abdominal Stent Graft with the Xcelerent System, Talent Converter Stent Graft with the Xcelerant SystemMedtronic Vascular
Santa Rosa, CA
95403
Modification of a wiping procedure.
P080004/S009
10/26/11
Hoya iSphericHoya Surgical Optics, Inc.
Chino Hills, CA
91709
Change to the endotoxin testing method.
P080007/S008
10/31/11
E-LUMINEXX Vascular Stent GraftC.R. Bard, Inc.
Tempe, AZ
85281
Introduction of an automated labeling inspection system and introduction of a new barcode scan system.
P090013/S039
10/13/11
Revo MRI IPGMedtronic, Inc.
Mounds View, MN
55112
Software updates for a testing application.
P090028/S001
10/21/11
VITROS Immunodiagnostic Products HBeAg Reagent Pack and VITROS Immunodiagnostic Products HBeAg CalibratorOrtho-Clinical Diagnostics, Inc.
Rochester, NY
14626
Conversion of the in-process limit for the process control of the selling calibrator from a signal ratio to a numerical test result.
P100010/S012
10/7/11
Freezor MAX Cardiac CryoAblation CatheterMedtronic CryoCath LP
Pointe Claire, Quebec
H9R5Z8
Change to reduce adhesive curing time for ECG rings and the tip electrode.
P100023/S020
10/6/11
ION (TAXUS Element) Paclitaxel-Eluting Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Addition of the ION Stent System to sterilization Chamber 6 at Coventry, Rhode Island.
P100023/S021
10/14/11
ION Paclitaxel-Eluting Platinum Chromium Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Change to the feedstock source for the manufacturing of a solvent.
P100023/S022
10/19/11
ION (TAXUS Element) Paclitaxel-Eluting Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Updates to the Hydrophilic Coating (HPC) equipment process.
P100023/S023
10/27/11
ION (Taxus Element) Paclitaxel-Eluting Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Change to the in-process monitoring plan for proximal and port welds.
P100023/S024
10/19/11
ION (TAXUS Element) Paclitaxel-Eluting Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Updates to the Marker Band and DVT equipment inspection software.
P100023/S025
10/28/11
ION (Taxus Element) Paclitaxel-Eluting Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Modification to the sampling plan for the laser cutting set up.
P100023/S026
10/31/11
ION (TAXUS Element) Paclitaxel-Eluting Coronary Stent SystemBoston Scientific Corporation
Maple Grove, MN
55311
Hardware and software updates for the Plasma Treater.
P100029/S009
10/19/11
Trifecta ValveSt. Jude Medical, Inc.
St. Paul, MN
55117
Change to the in-process limit for total valve score during the visual inspection and functional test.
P110020/S001
10/17/11
cobas® 4800 BRAF V600 mutation testRoche Molecular Systems, Inc.
Pleasanton, CA
94588
Addition of functional testing at the final vial stage in the manufacture of the device mutation positive control (MU) and the wild-type control (WT).
P110020/S002
10/26/11
cobas® 4800 BRAF V600 mutation testRoche Molecular Systems, Inc.
Pleasanton, CA
94588
Changes to the filling and labeling equipment and location for certain vialed intermediate components. The firm has proposed relocation to Building 502 Rooms 1F24 and 1F26 from Building 502 Rooms 1F23 and 1F31 for use of new equipment Kugler Linoline 120 Filing and Screw-capping Line which includes the Accraply 4000 and 35T Labeling Machines.

Summary of PMA Originals & Supplements Approved
Originals: 4
Supplements: 52

Summary of PMA Originals Under Review
Total Under Review: 88
Total Active: 41
Total On Hold: 47
Number Greater Than 180 Days: 3

Summary of PMA Supplements Under Review
Total Under Review: 554
Total Active: 437
Total On Hold: 117
Number Greater Than 180 Days: 11

Summary of All PMA Submissions Received
Originals: 2
Supplements: 66

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 52
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 210.9
FDA Time: 127.9 Days MFR Time: 83 Days