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U.S. Department of Health and Human Services

Medical Devices

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May 2013 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
P080009
5/3/13
SEDASYS® Computer-Assisted Personalized Sedation SystemEthicon Endo-Surgery, Incorporated
Cincinnati, OH
45242
Approval for the SEDASYS® Computer-Assisted Personalized Sedation System. This device is indicated for the intravenous administration of 1% (10 mg/mL) propofol injectable emulsion for the initiation and maintenance of minimal to moderate sedation, as defined by the American Society of Anesthesiologists (ASA) Continuum of Depth of Sedation, in ASA physical status I and II patients ≥ 18 years old undergoing colonoscopy and esophagogastroduod-denoscopy (EGD) procedures.
P120014
5/29/13
THxID™ BRAF Kit for use on the ABI 7500 Fast Dx Real-Time PCR InstrumentbioMerieux, Inc.
Hazelwood, MO 63042
Approval for the THxID™ BRAF Kit for use on the ABI 7500 Fast Dx Real-Time PCR Instrument. This device is indicated for: The THxIDTM BRAF kit is an In Vitro Diagnostic device intended for the qualitative detection of the BRAF V600E and V600K mutations in DNA samples extracted from formalin-fixed paraffinembedded (FFPE) human melanoma tissue. The THxID™ BRAF kit is a real-time PCR test on the ABI 7500 Fast Dx system and is intended to be used as an aid in selecting melanoma patients whose tumors carry the BRAF V600E mutation for treatment with dabrafenib [Tafinlar®] and as an aid in selecting melanoma patients whose tumors carry the BRAF V600E or V600K mutation for treatment with trametinib [Mekinist™].
P120019
5/14/13
cobas® EGFR Mutation TestRoche Molecular Systems, Inc.
Pleasanton, CA
94588
Approval for the cobas® EGFR Mutation Test. The cobas® EGFR Mutation Test is a real-time PCR test for the qualitative detection of exon 19 deletions and exon 21 (L858R) substitution mutations of the epidermal growth factor receptor (EGFR) gene in DNA derived from formalin-fixed paraffin-embedded (FFPET) human non-small cell lung cancer (NSCLC) tumor tissue. The test is intended to be used as an aid in selecting patients with metastatic NSCLC for whom Tarceva® (erlotinib), an EGFR tyrosine kinase inhibitor (TK1), is indicated. Specimens are processed using the cobas® DNA Sample Preparation Kit for manual sample preparation and the cobas z 480 analyzer for automated amplification and detection.

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
P820003/S117
5/30/13
180-Day
Versatrax Pacing SystemMedtronic, Inc.
Mounds View, MN 55112
Approval for the implementation of a DF-4 lead compatible, crimpable alligator clip onto the Surgical Cables, process improvements for the splice yoke of the cables and a change to the wire gauges used in the 2292 cable assembly.
P850064/S021
5/16/13
180-Day
LifePulse High Frequency VentilatorBunnell, Incorporated
Salt Lake City, UT 84115
Approval for a change in the insulation material on the raw heater wire in the patient circuit.
P860003/S068
5/1/13
180-Day
THERAKOS® CELLEX® Photopheresis SystemTHERAKOS, Inc.
Raritan, NJ
08869
Approval for software changes to the THERAKOS® CELLEX® Photopheresis System (software Version 4.1).
P860004/S191
5/23/13
Special
Medtronic SynchroMed Infusion SystemMedtronic Neuromodulation
Minneapolis, MN 55432
Approval of labeling changes for device refill kit Model 8551 to accommodate the possibility for the use of multiple syringes during kit refill procedures.
P890003/S265
5/30/13
180-Day
 Synergyst II Pacing SystemMedtronic, Inc.
Mounds View, MN 55112
Approval for the implementation of a DF-4 lead compatible, crimpable alligator clip onto the Surgical Cables, process improvements for the splice yoke of the cables and a change to the wire gauges used in the 2292 cable assembly.
P890003/S269
5/24/13
180-Day
MyCareLink Patient Monitor and
Accessories
Medtronic, Inc.
Moundsview, MN 55112
Approval for the MyCareLink Patient Monitor Models 24950, 24951, Reader Model 24955, and accessories, which support the devices.
P910056/S014
5/15/13
135-Day
enVista Intraocular LensBausch & Lomb, Inc.
Aliso Viejo, CA 92656
Addition of an alternate packaging component supplier for the enVista Intraocular Lens Model MX60 vial package.
P910073/S116
5/7/13
Real-Time
 Endotak Lead SystemBoston Scientific
St. Paul, MN
55112
Approval for an alternate primer material for the FLEXTEND and Active Fixation Reliance IS-1/4-SITE leads.
P950037/S121
5/8/13
Real-Time
Philos DR-T, Philos II DR-T, Cylos
DR-T, Evia DR-T/ Evia SR-T, Entovis DR-T/Entovis SR-T, Estella DR-T/ Estella SR-T
Biotronik, Inc.
Lake Oswego, OR 97035
Approval for an updated Version 3.22.0 of Home Monitoring Service Center including the features: 1) Implementation of Remote Scheduling; and 2) Automatic export of EHR data.
P960006/S038
5/7/13
Real-Time
FLEXTEND LeadsBoston Scientific
St. Paul, MN
55112
Approval for an alternate primer material for the FLEXTEND and Active Fixation Reliance IS-1/4-SITE leads.
P960058/S098
5/20/13
180-Day
HiResolution Bionic Ear System
HiFocus™ Mid-Scala Electrode for HiRes 90K™ Advantage Cochlear Implant
Advanced Bionics,
Sylmar, CA
91342
Approval for an alternate electrode configuration for the HiRes 90K™ Advantage Cochlear Implant device, the "Hi Focus™ Mid-Scala Electrode.”
P970003/S158
5/2/13
Real-Time
VNS Therapy SystemCyberonics, Inc.
Houston, TX,
77058
Approval for a new torque wrench model featuring a “recessed nose” design.
P970029/S024
5/31/13
Real-Time
TMR2000 Holmium Laser SystemCardiogenesis, Inc.
Kennesaw, GA 30144
Approval for design changes to the distal fibers of the three hand-piece models. The device, as modified, will be marketed under the trade name TMR2000 Holmium Laser System and is indicated for trans-myocardial revascularization in patients with angina refractory to medical treatment and secondary to objectively demonstrated coronary artery atherosclerosis and with a region of the myocardium with reversible ischemia not amenable to direct coronary revascularization.
P970051/S091
5/28/13
180-Day
Nucleus Cochlear Implant System – Aqua Accessory for the Nucleus 5 (CP810) Sound ProcessorCochlear Americas
Centennial, CO 80111
Approval for the Aqua Accessory for the Nucleus Cochlear Implant System. The Aqua Accessory is a water resistant pouch that is sealable at one end, and holds the external Nucleus 5 CP810 sound processor and coil. It may be used for up to an hour to keep the external components dry during use in water (e.g., swimming). The Aqua Accessory is intended for unilateral or bilateral use by cochlear implant recipients who have the ability to notify a caregiver or the ability to remove the device on their own, if the device becomes hot or if there is a change in sound quality.
P980016/S400
5/24/13
180-Day
EnTrust ICD; Intrinsic 30 ICD;
Intrinsic ICD; Marquis DR ICD; Marquis VR ICD; Maximo DR ICD; Maximo VR ICD
Medtronic, Inc.
Moundsview, MN 55112
Approval for the MyCareLink Patient Monitor Models 24950, 24951, Reader Model 24955, and accessories, which support the devices.
P980023/S052
5/8/13
Real-Time
Belos VR-TBiotronik, Inc.
Lake Oswego, OR 97035
Approval for an updated Version 3.22.0 of Home Monitoring Service Center including the features: 1) Implementation of Remote Scheduling; and 2) Automatic export of EHR data.
P980035/S311
5/24/13
180-Day
Adapta, Versa, Sensia IPG; Advisa DR IPG; Advisa DR MRI IPG; EnPulse E1 IPG; EnPulse E2 IPG; EnRhythm IPG; Kappa D (Kappa 700) IPG; Kappa D (Kappa 900) IPG; Kappa DR (Kappa 650) IPG; Kappa DR (Kappa 700/600) IPG; Kappa DR (Kappa 900/800) IPG; Kappa SR (Kappa 700) IPG; Kappa SR (Kappa 900) IPG; Kappa VDD (Kappa 700) IPGMedtronic, Inc.
Moundsview, MN 55112
Approval for the MyCareLink Patient Monitor Models 24950, 24951, Reader Model 24955, and accessories, which support the devices.
P980035/S317
5/15/13
Real-Time
Advisa DR MRI IPGMedtronic, Inc.
Moundsview, MN 55112
Approval for two minor design changes to the L310 Integrated Circuit for the Advisa DR MRI device.
P980049/S071
5/9/13
180-Day
Paradym RF VR Model 9250 and DR Model 9550Sorin CRM USA, Inc.
Plymouth, MN 55441
Approval for the Smartview Home Monitor. The device, as modified, will be marketed under the trade name Smartview Home Monitor and is indicated for use with Sorin radio frequency implanted cardiac device only and any household traditional (analog type) telephone land line; It will not operate with other lines such as and not limited to digital, DSL or optical for the PSTN device and the SMARTVIEW monitor is designed for use with the Sorin radio frequency implanted cardiac device only for GPRS devices.
P990012/S016
5/14/13
135-Day
Elecsys® HBsAg Immunoassay, Elecsys® PreciControl HBsAg, and Elecsys® HBsAg
Confirmatory Test
Roche Diagnostics Corporation
Indianapolis, IN 46250
Approval for a change to the specifications for the negative human serum incoming material.
P990027/S018
5/17/13
180-Day
TECHNOLAS® 217z Zyoptix SystemTechnolas® Perfect Vision, Gmbh
Lutz, FL
33558
Approval for the addition of the advanced Planoscan software to be used with the device.
P000006/S033
5/31/13
Real-Time
Titan Inflatable Penile ProsthesisColoplast Corporation
Minneapolis MN 55411
Approval for modifications to the deflation button and valve of the pump component, and related changes to the labeling to reflect these modifications.
P000009/S054
5/8/13
Real-Time
Belos DR-T, Belos A+-T, Lexos DR-T/ Lexos VR-T, Xelos DR-T, Lumos
DR-T/Lumos VR-T
Biotronik, Inc.
Lake Oswego, OR 97035
Approval for an updated Version 3.22.0 of Home Monitoring Service Center including the features: 1) Implementation of Remote Scheduling; and 2) Automatic export of EHR data.
P000025/S068
5/16/13
Real-Time
MED-EL COMBI 40+ Cochlear Implant System and
MED-EL Reusable Mi1000 PIN Drill Guide
MED-EL Corporation
Durham, NC
27713
Approval for the reusable Mi1000 PIN Drill Guide which assists in the surgical implantation of the approved Mi1000 CONCERT PIN implant.
P000029/S074
5/22/13
Special
Deflux® Injectable GelSalix Pharmaceuticals, Inc.
Raleigh, NC
27615
Approval for update to the information for post-approval adverse reactions and update on the labeling of the sponsor name and contact information.
P000040/S027
5/16/13
180-Day
Genesys HT A System ProCerva Procedure SetBoston Scientific Corporation
Marlborough, MA 01752
Approval for a manufacturing sites located at Boston Scientific Corporation, in Spencer, Indiana, and Boston Scientific Corporation, in Coventry, Rhode Island.
P000054/S039
5/31/13
Special
INFUSE™ Bone GraftMedtronic Sofamor Danek USA, Inc.
Memphis, TN
38132
Approval for modifications to the package insert to reflect the results of Study 400.
P010015/S190
5/24/13
180-Day
Consulta and Syncra CRT-PMedtronic, Inc.
Moundsview, MN 55112
Approval for the MyCareLink Patient Monitor Models 24950, 24951, Reader Model 24955, and accessories, which support the devices.
P010031/S363
5/24/13
180-Day
InSync III Marquis, InSync Marquis, InSync Maximo,  Insync II ProtectMedtronic, Inc.
Moundsview, MN 55112
Approval for the MyCareLink Patient Monitor Models 24950, 24951, Reader Model 24955, and accessories, which support the devices.
P010032/S061
5/8/13
135-Day
Genesis Pulse Generator, 8-Channel Neurostimulation System, GenesisXP Pulse Generator, 8-Channel Neurostimulation System, Genesis Pulse Generator, Dual4 Channel Neurostimulation System,
GenesisXP Pulse Generator, Dual4 Channel Neurostimulation System, GenesisRC Pulse Generator Neurostimulation System, GenesisRC Pulse Generator, Dual4 Channel Neurostimulation System
St. Jude Medical
Plano, Texas
75024
Approval to eliminate the use of liquid no-clean solder flux and to change the solid flux core wire used in the soldering process.
P010032/S068
5/17/13
Real-Time
Eon Mini Implantable Pulse Generators (IPG) Neurostimulation SystemSt. Jude Medical
Plano, TX
75024
Approval for changes to the Eon Mini Implantable Pulse Generator (IPG) model 3788 software.
P010059/S004
5/23/13
180-Day
Capsular Tension Rings and Pre-loaded EYEJECT Injectors with Capsular Tension RingsMorcher GmbH
Centerville, MA 02632
Approval for the expansion of your family of capsular tension rings (CTRs) available pre-loaded on the EYEJET injector to include new CTR models Type 10G, 10L, 15, 15A, and 15B. In addition, you requested approval to supply currently approved CTR Type 10C as pre-loaded on the EYEJET injector.
P020018/S048
5/9/13
180-Day
The Zenith Fenestrated AAA Endovascular GraftCook Incorporated
Bloomington, IN 47402
Approval of the post-approval study protocol.
P020050/S013
5/15/13
Special
WaveLight® EX 500 Excimer Laser SystemAlcon Research, Ltd.
Fort Worth, TX 76134
Approval for the labeling changes of WaveLight® EX 500 Excimer Laser System and WaveLight Laser System.
P030002/S027
5/20/13
Panel-Track
Trulign™ Toric Posterior Chamber Intraocular Lens
(Models: AT50T, BL1AT and BLU1T) and Trulign™ Toric Calculator
Bausch + Lomb
Aliso Viejo, CA 92656
Approval for the Trulign™ Toric Posterior Chamber Intraocular Lens (Models: AT50T, BL1AT and BL1UT) and Trulign™ Toric Calculator.  This device is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia and postoperative refractive astigmatism secondary to removal of a cataractous lens in adult patients with or without presbyopia who desire reduction of residual refractive cylinder with increased spectacle independence and improved uncorrected near, intermediate and distance vision.
P030005/S092
5/23/13
180-Day
Intua CRT-PBoston Scientific Corporation
St. Paul, MN
55112
Approval for the Intua CRT-P.
P030008/S011
5/15/13
Special
WaveLightLaser SystemAlcon Research, Ltd.
Fort Worth, TX 76134
Approval for the labeling changes of WaveLight® EX 500 Excimer Laser System and WaveLight Laser System.
P030011/S019
5/30/13
135-Day
SynCardia temporary Total Artificial Heart (TAH-t) SystemSynCardia Systems, Inc.
Tucson, AZ
85713
Approval for expansion of your controlled environment suite manufacturing area.
P030017/S156
5/8/13
Real-Time
Precision Spinal Cord Stimulation SystemBoston Scientific Neuromodulation
Valencia, CA
91355
Approval for a colorant change to the hub portion of the Introducer, a surgical accessory for the Precision Spinal Cord Stimulation System that is used to facilitate placement of a lead into the epidural space.
P030017/S157
5/30/13
Real-Time
 
Precision Spinal Cord Stimulator (SCS) – Clinical ProgrammerBoston Scientific Neuromodulation (BSN)
Valencia, CA
91355
Approval for an update to the Clinician Programmer computer used with the Precision and Precision Spectra Spinal Cord Stimulator (SCS) systems. A tablet computer from ASUS, model EEE Slate B121, will be used to replace the current Clinician Programmer, a Toshiba model M400 laptop computer. The ASUS tablet is an off-the-shelf computer, customized to be a Clinician’s Programmer by installing the EEE Slate B121 boot and image software and configuring the system with the BN1.2 and BN3 BionicNavigator software.
P030050/S014
5/28/13
Real-Time
Sculptra and Sculptra AestheticValeant Pharmaceuticals North America LLC
North Bridgewater, NJ
08807
Approval for the revision of a Precaution statement in your product label to state: SCULPTRA Aesthetic should only be used by a healthcare practitioner trained to correct shallow to deep nasolabial contour deficiencies and other facial wrinkles, in which deep dermal grid pattern (cross-hatch) injection technique is appropriate, after the healthcare practitioner is fully familiar with the product, WAS, product educational materials, and the entire package insert and patient labeling. The device, as modified, will be marketed under the trade name Sculptra Aesthetic and is indicated for use in immune-competent people as a single regimen for correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles in which deep dermal grid pattern (cross-hatch) injection technique is appropriate.
P040044/S048
5/17/13
Real-Time
Mynx Vascular Closure Device Product FamilyAccess Closure, Inc.
Mountain View, CA 94043
Approval for clarification and simplification of the language used in the instruction for use and removal of the sterilization indicator label from the device pouch for the Mynx Cadence Vascular Closure Device, 6F/7F MynxGrip Vascular Closure Device, and 5F MynxGrip Vascular Closure Device.
P050018/S018
5/20/13
180-Days
AngioSculpt PTCA Scoring Balloon CatheterAngioScore, Inc.
5055 Brandin Court
Fremont, CA
94538
Approval for revisions to the Instructions for Use labeling
P050023/S063
5/8/13
Real-Time
Lumax 300 DR-T/ Lumax 340 DR-T, Lumax 300 VR-T/ Lumax 340 VR-T, Lumax 500 DR-T/ Lumax 540 DR-T, Lumax 500 VR-T/ Lumax 540 VR-T, Lumax 540 VR-T DX, Lumax 600 DR-T/ Lumax 640 DR-T, Lumax 600 VR-T/ Lumax 640 VR-T, Lumax 640
VR-T DX, Lumax 700 DR-T/ Lumax 740 DR-T, Lumax 700 VR-T/ Lumax 740 VR-T, Lumax 740 VR-T DX, Ilesto 7 VR-T/ Ilesto 5 VR-T, Ilesto 7 VR-T DX/Ilesto 5 VR-T DX, Ilesto 7 DR-T/ Ilesto 5 DR-T, Iforia 7 VR-T/ Iforia 5 VR-T, Iforia 7 VR-T DX/
Iforia 5 VR-T DX, Iforia 7 DR-T/ Iforia 5 DR-T, Kronos LV-T, Lumax 300 HF-T/ Lumax 340 HF-T, Lumax 500 HF-T/ Lumax 540 HF-T, Lumax 600 HF-T / Lumax 640
HF-T, Lumax 700 HF-T/ Lumax 740 HF-T, Ilesto 7
HF-T/Ilesto 5 HF-T, Iforia 7 HF-T/Iforia 5 HF-T
Biotronik, Inc.
Lake Oswego, OR 97035
Approval for an updated Version 3.22.0 of Home Monitoring Service Center including the features: 1) Implementation of Remote Scheduling; and 2) Automatic export of EHR data.
P050028/S030
5/3/13
Real-Time
COBAS® AmpliPrep/ COBAS® TaqMan® HBV Test, v2.0Roche Molecular Systems, Inc.
Pleasanton, CA 94588
Approval for changes to the Test Definition File (TDF) in order to implement a new sample preparation sequence for the Cobas AmpliPrep instrument.
P050050/S004
5/1/13
180-Day
Scandinavian Total Ankle Replacement (STAR) SystemSmall Bone Innovations, Inc.
Morrisville, PA
19067
Approval for a manufacturing site located at Zrinski Ag in Wurmlingen, Germany.
P060008/S097
5/1/13
180-Day
TAXUS Liberté Paclitaxel-Eluting Coronary Stent SystemBoston Scientific Corporation
MN
55311
Approval for the labeling update for post approval study findings for the TAXUS Liberté Paclitaxel-Eluting Coronary Stent System.
P060025/S010
5/29/13
Real-Time
3f Aortic BioprosthesisMedtronic Heart Valves
Santa Ana, CA 92705
Approval for changes to the rinsing and fixations solutions used in the manufacture of the device. The device, as modified, will be marketed under the trade name 3f Aortic Bioprosthesis, Model 1000 and is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.
P060027/S038
5/9/13
180-Day
Paradym RF CRT-D 9750Sorin CRM USA, Inc.
Plymouth, MN 55441
Approval for the Smartview Home Monitor. The device, as modified, will be marketed under the trade name Smartview Home Monitor and is indicated for use with Sorin radio frequency implanted cardiac device only and any household traditional (analog type) telephone land line; It will not operate with other lines such as and not limited to digital, DSL or optical for the PSTN device and the SMARTVIEW monitor is designed for use with the Sorin radio frequency implanted cardiac device only for GPRS devices.
P060040/S023
5/7/13
180-Day
Thoratec HeartMate II Left Ventricular Assist System (LV AS)Thoratec Corporation
Pleasanton, CA 94588
Approval for a new System Controller for the device.
P070008/S041
5/8/13
Real-Time
Stratos LV-T, Evia HF-TBiotronik, Inc.
Lake Oswego, OR 97035
Approval for an updated Version 3.22.0 of Home Monitoring Service Center including the features: 1) Implementation of Remote Scheduling; and 2) Automatic export of EHR data.
P070015/S109
5/23/13
180-Day
XIENCE V Everolimus Eluting Coronary Stent SystemAbbott Vascular, Inc.
Santa Clara, CA 95052
Approval of the post-approval study protocol.
P070016/S007
5/20/13
Special
Zenith TX2 Thoracic Endovascular Fenestrated Stent GraftCook Incorporated
Bloomington, IN 47402
Approval for updating several sections in the IFU regarding maintaining hemostasis, trigger wire release, and MRI safety information.
P070026/S013
5/7/13
Special
DePuy CERMAX® Ceramic Total Hip SystemDePuy Orthopaedics, Incorporated
Warsaw, IN
46581
Approval for a change in the labeling of the package insert and surgical technique.
P080003/S001
5/16/13
Panel-Track
Selenia Dimensions 3D SystemHologic, Inc.
Bedford, MA
01730
Approval for the Selenia Dimensions 3D System.  This device is indicated to generate digital mammographic images that can be used for screening and diagnosis of breast cancer. The Selenia Dimensions (2D or 3D) system is intended for use in the same clinical applications as a 2D mammography system for screening mammograms. Specifically, the Selenia Dimensions system can be used to generate 2D digital mammograms and 3D mammograms. Each screening examination may consist of: a 2D FFDM image set; or a 2D and 3D image set, where the 2D image can be either a FFDM or a 2D image generated from the 3D image set. The Selenia Dimensions system may also be used for additional diagnostic workup of the breast.
P080012/S017
5/16/13
Special
Prometra Programmable Infusion SystemFlowonix Medical, Incorporated
Mt. Olive, NJ
07828
Approval for an MRI information bracelet.
P080027/S011
5/28/13
Special
OraQuick® HCV Rapid Antibody TestOraSure Technologies, Inc.
Bethlehem, PA 18015
Approval of the addition of a visual inspection step in the OraQuick® HCV Rapid Antibody Test Assay Card manufacturing process.
P090013/S085
5/24/13
180-Day
Revo MRIMedtronic, Inc.
Moundsview, MN 55112
Approval for the MyCareLink Patient Monitor Models 24950, 24951, Reader Model 24955, and accessories, which support the devices.
P090018/S019
5/17/13
Special
Esteem® Implantable Hearing SystemEnvoy Medical Corporation
St Paul, MN
55110
Approval for the following: 1) revisions to the instructions for use for the implanting surgeon; 2) a manual to inform audiologists on the programming of the Esteem System; and 3) for making manuals, which are made redundant by the former labeling changes, obsolete.
P100012/S004
5/3/13
180-Day
NuVasive PCM Cervical DiscNuvasive, Inc.
San Diego, CA 92121
Approval of the post-approval study protocol.
P100016/S001
5/28/13
180-Day
Aaris™ Acrylic Intraocular Lens (IOL), and EC-3 Precision Aspheric Lens (PAL)Aaren Scientific Inc.
Ontario, CA
91761
Approval for a change to the trade name of the approved lenses and labeling changes to the unit carton, including a change to the color scheme and format. The device, as modified, will be marketed under the trade name Aaris™ Acrylic Intraocular Lens (IOL), Models EC-3 and EC-3 Precision Aspheric Lens (PAL) and is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed.
P100021/S024
5/3/13
180-Day
Endurant II Stent Graft SystemMedtronic Vascular, Inc.
Santa Rosa, CA 95403
Approval for a sterilization site located at Synergy Health Sterilization UK LTD in Daventry, United Kingdom.
P100023/S069
5/15/13
180-Day
ION Paclitaxel-Eluting Platinum Chromium Coronary Stent System
(Monorail and OTW)
Boston Scientific Corporation
Maple Grove, MN 55311
Approval for a manufacturing site located at Ballybrit Business Park, in Galway, Ireland.
P100025/S002
5/23/13
180-Day
BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit) and Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA)Otsuka America Pharmaceutical, Inc.
Rockville, MD 20850
Approval for a manufacturing site located at Sharp Corporation, in Allentown, PA.
P100025/S004
5/29/13
180-Day
BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit) and Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA), Version 1.0Otsuka America Pharmaceutical, Inc.
Rockville, MD 20850
Approval for changes to the labeling for the BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit) and Pediatric Urea Hydrolysis Rate Calculation application (pUHR-CA), Version 1.0, including the package insert and How to Guide.
P100041/S027
5/22/13
Special
Edwards SAPIEN™ Transcatheter Heart Valve Crimper, and all SAPIEN™ AccessoriesEdwards Lifesciences, LLC
Irvine, CA 92614
Approval for addition of polyethylene foam to the base of the Crimper during packaging, a change to the Crimper package release temperature set point, and addition of pouch integrity inspections for all SAPIEN™ accessories.
P100044/S004
5/22/13
180-Day
Propel™ Sinus ImplantIntersect ENT
Menlo Park. CA
94025
Approval for a revised drug release specification range for the drug release test per a condition of approval.
P100047/S014
5/15/13
180-Day
HeartWare Ventricular Assist SystemHeartWare Inc.
Miami Lakes, FL 33014
Approval for a manufacturing site located at Heart Ware in Miami Lakes, Florida.
P100047/S019
5/22/13
Real-Time
HeartWare® Ventricular Assist SystemHeartWare Inc.
Miami Lakes, FL 33014
Approval for a change of the adhesive tape and the addition of 4 ribs (posts/shelves) to hold the LCD glass in its position on the controller.
P110007/S003
5/28/13
135-Day
Healon EndoCoat Ophthalmic Viscoelastic Devices (OVD)Abbott Medical Optics Inc.
Santa Ana, CA 92705
Approval for the use of a new raw material supplier for the nutrient source used in the sodium hyaluronate manufacturing process.
P110021/S013
5/22/13
Special
Edwards SAPIEN™ Transcatheter Heart Valve Crimper and all SAPIEN™ AccessoriesEdwards Lifesciences, LLC
Irvine, CA
92614
Approval for addition of polyethylene foam to the base of the Crimper during packaging, a change to the Crimper package release temperature set point, and addition of pouch integrity inspections for all SAPIEN™ accessories.
P110042/S005
5/9/13
Real-Time
Programmer Model Q-TECHCameron Health Inc.
San Clemente, CA 92673
Approval for disabling of the Programmer Model Q-TECH modem port.

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

APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
P790005/S049
5/28/13
EBI OsteoGen™ Implantable Bone Growth StimulatorsBiomet Spine & Bone Healing Technologies
Parsippany, NJ 07054
Acceptance of a replacement coin cell battery.
P810002/S085
5/30/13
St. Jude Medical Mechanical Heart ValvesSt. Jude Medical
St. Paul, MN
55117
Change to the clean room for the SJM Mechanical Heart Valves, and a change in the VAVGJ package sealing parameters.
P820021/S036
5/8/13
Vifilcon A Contact Lenses for Extended WearCIBA Vision Corporation
Duluth, GA
30097
Test method changes and/or improvements.
P830061/S091
5/23/13
CapSure Sense Bipolar LeadMedtronic, Inc.
Mounds View, MN 55112
Use of a new sterilizer and aerator.
P830061/S092
5/29/13
CapSure Lead,
Vitatron Crystaline Lead, Vitatron Excellence PS+ Lead
Medtronic, Inc.
Mounds View, MN 55112
Update to the maximum sterilization load profile temperature.
P840001/S239
5/16/13
Vectris™ SureScan® MRI 1X8 Leads and
Vectris™ 1X8 Trialing Leads
Medtronic Neuromodulation
Minneapolis, MN 55432
Modifications to the manufacturing process for leads used with implantable neurostimulators, external neurostimulators, and accessories for spinal cord stimulation.
P840060/S040
5/21/13
PMMA Posterior Chamber Intraocular LensesAlcon Research Ltd.
Fort Worth, TX 76134
Relocate packaging and labeling equipment.
P850035/S035
5/28/13
SpF® Implantable Spinal Fusion StimulatorsBiomet Spine & Bone Healing Technologies
Parsippany, NJ 07054
Acceptance of a replacement coin cell battery.
P850089/S097
5/29/13
CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Impulse II LeadMedtronic, Inc.
Mounds View, MN 55112
Update to the maximum sterilization load profile temperature.
P860003/S73
5/6/13
THERAKOS CELLEX Photopheresis System (CELLEX System)Therakos, Inc.
Raritan, NJ
08869
Manufacturing process change for one of the CELLEX System components.
P880006/S086
5/14/13
Regency, Sensolog, DialogSt. Jude Medical
Sylmar, CA
91342
Alternate sterilization cycle at the Puerto Rico manufacturing facility.
P880086/S232
5/15/13
AddVent, Affinity, Identity, Verity, Integrity, Victory, Zephyr,
Accent, Trilogy, Synchrony, Paragon, Phoenix, Entity, Sustain XL
St. Jude Medical
Sylmar, CA
91342
Alternate sterilization cycle at the Puerto Rico manufacturing facility.
P880086/S233
5/30/13
Identity, Verity, Integrity, Victory, Zephyr, Accent family of Pacemaker DevicesSt. Jude Medical
Sylmar, CA
91342
Alternate assembly process for attaching the X-Ray Tag to the hybrid.
P880087/S022
5/21/13
PMMA Single-Piece AnteriorAlcon Research Ltd.
Fort Worth, TX 76134
Relocate packaging and labeling equipment.
P890003/S275
5/29/13
CapSure LeadMedtronic, Inc.
Mounds View, MN 55112
Update to the maximum sterilization load profile temperature.
P900052/S018
5/13/13
Port-A-Cath Low Profile Epidural Implantable Access SystemSmiths Medical ASD, Inc.
St. Paul, MN
55112
Change in the synthesis of polytetrafluoro-ethylene (PTFE), a substance used in the manufacturing of the coating system for the guidewire contained in the Port-A-Cath II Low Profile Epidural Implantable Access System. This change in the synthesis of PTFE is required to conform to U.S. Environmental Agency 2010/2015 PFOA Stewardship Program related to the use of perfluorooctanoic acid (PFOA).
P910023/S314
5/14/13
Cadence, Cadet, Contour, Contour II/MD, Angstrom II/MD, Profile
II/MD, Photon, Photon Micro, Current, Current +, Atlas II/Atlas II+,
Atlas/Atlas +, Epic II/Epic II+, Epic/Epic +, Convert/Convert +,
Current RF,
Current +, Current Accel, Fortify, Fortify Assura, Ellipse
St. Jude Medical
Sylmar, CA
91342
Alternate sterilization cycle at the Puerto Rico manufacturing facility.
P920015/S111
5/29/13
Sprint Quattro Lead, Subcutaneous Lead, Transvene SVC LeadMedtronic, Inc.
Mounds View, MN 55112
Update to the maximum sterilization load profile temperature.
P930014/S068
5/21/13
AcrySof Intraocular LensesAlcon Research Ltd.
Fort Worth, TX 76134
Relocate packaging and labeling equipment.
P930039/S087
5/23/13
CapSureFix Novus LeadMedtronic, Inc.
Mounds View, MN 55112
Use of a new sterilizer and aerator.
P930039/S088
5/29/13
CapSureFix Lead, CapSureFix Novus
Lead, SureFix Lead, Vitatron Crystalline Lead, Vitatron Pirouet Lead
Medtronic, Inc.
Mounds View, MN 55112
Update to the maximum sterilization load profile temperature.
P950005/S044
5/29/13
Celsius, Celsius RMT, EZ Steer Non-Temp Sensing Ablation CathetersBiosense Webster, Inc.
Diamond Bar, CA 91765
Addition of an alternate supplier for the extrusion and braiding process for the family of products.
P950008/S009
5/15/13
Silikon 1000 Ocular EndotamponadeAlcon Laboratories, Inc.
Fort Worth, TX
76134
Alternate thermal extraction.
P950022/S086
5/29/13
Durata Family of High Voltage LeadsSt. Jude Medical
Sylmar, CA
91342
Add an alternate supplier of a lead tip component.
P950024/S049
5/29/13
CapSure Epicardial Pacing LeadMedtronic, Inc.
Mounds View, MN 55112
Update to the maximum sterilization load profile temperature.
P950037/S122
5/17/13
Dextrus, Selox, Setrox S, Solox, Tilda LeadsBiotronik, Inc.
Lake Oswego, OR 97035
Use a new maximum sterilization chamber load at the contract sterilizer for their marketed leads.
P950037/S123
5/29/13
Selox, Setrox S, Solox, Ecuro, Effecta, Estella, Evia, DextrusBiotronik, Inc.
Lake Oswega, OR 97035
A change in sterilization load configuration; 2) change in sterilization pre-conditioning; 3) sterilization injection parameter changes; and 4) change to the process challenge device.
P960009/S171
5/29/13
Deep Brain Stimulation (DBS) LeadsMedtronic, Inc.
Minneapolis, MN 55432
Implement a new inspection process to verify the distal end surface straightness of the DBS leads.
P960013/S075
5/29/13
Tendril STS Model 2088TC LeadSt. Jude Medical
Sylmar, CA
91342
Add an alternate supplier of a lead tip component.
P970003/S161
5/3/13
VNS Therapy® System – Lead AssemblyCyberonics, Inc.
Houston, TX
77058
Addition of an alternative elastomer mixing process for various lead assembly models.
P970003/S163
5/21/13
VNS Therapy® Generator (Pulse and Pulse Duo),
VNS Therapy® Generator (AspireHC)
Cyberonics, Inc.
Houston, TX
77058
Addition of an alternative laser welding system, which is used to weld the case halves and anchor tabs of the VNS Therapy® Generators.
P970013/S056
5/14/13
MicronySt. Jude Medical
Sylmar, CA
91342
Alternate sterilization cycle at the Puerto Rico manufacturing facility.
P970051/S109
5/6/13
Nucleus 24 Cochlear Implant SystemCochlear Americas
Centennial, Colorado 80111
Upgrades to the Nucleus 5 Service Test System software.
P980016/S407
5/3/13
Intrinsic, Marquis, Marquis, Maximo II, Maximo, Protecta, Protecta XT,
Secura, Virtuoso II, Evera S, and Evera XT ICD Families
Medtronic, Inc.
Mounds View, MN 55112
Implementation of an updated acceptance criterion for evaluation of insulator materials used in the manufacture of the subject ICDs and CRT-D devices.
P980016/S408
5/3/13
Evera S DR, Evera S VR, Evera XT DRMedtronic CRDM
Mounds View, MN 55112
Addition of a specific acceptance criterion to allow delamination for the lower wire bond pad on the U31 FET; 2) two process adjustment changes for the integrated circuit at Medtronic supplier 3) the implementation of additional tooling for the case liner assembly manufacturing Process; 4) a change to the hybrid CD Surge manufacturing test software; 5) three changes including the implementation of a burn-in oven for the recovery and final voltage measurements steps for the batteries of the subject devices, corrections to the subject systems' battery test specification to align with measurement system capabilities, and consolidation of measurement steps within the burn in test process; and 6) the implementation of additional laser welders to increase manufacturing capacity.
P980016/S409
5/3/13
Evera S DR, Evera S VR, Evera XT DRMedtronic CRDM
Mounds View, MN 55112
The implementation of FACTORY works Release 8.0 and MES Web Services Release 2.1; 2) the approval of manufacturing lines in a new extension of a controlled environment area; 3) new pressure test equipment to verify hermeticity; 4) modifications to a controlled environment; 5) a change to the descum and cleaning process for the 3um CMOS Integrated Circuit; and 6) a new software version for process data collection software at a Medtronic supplier.
P980016/S410
5/7/13
Evera S DR, Evera S VR, Evera XT DR, Evera XT VR,Medtronic, Inc.
Mounds View, MN 55112
Seven previously approved manufacture changes for the devices. Those are: 1) update the CMOS IC Process Flow Changes at your supplier; 2) update the test software and hardware on the Teradyne Test Platform for M019 and M017 ICs; 3) add the High Temperature Monitor to High Power Lean Line; 4) update the Automated Assembly Equipment Controller (AAEC); 5) implement a new Cleaning process and a Curing Oven; 6) implement a manufacturing execution system version 7.9 at various internal suppliers and final device manufacturing locations; and 7) update to the Test System Software Shell.
P980016/S414
5/14/13
Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR
ICD, Maximo II ICD, Protecta ICD, Protecta XT ICD, Secura ICD,
Virtuoso II DR/VR ICD
Medtronic, Inc.
Mounds View, MN 55112
Butted Contact etch time change for the M016 and M017 Integrated Circuits.
P980016/S415
5/22/13
Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Maximo II ICD, Protecta ICD, Protecta XT ICD, Secura ICD, Virtuoso II DR/VR ICDMedtronic, Inc.
Mounds View, MN 55112
 
Second source supplier for a thick film chip resistor.
P980023/S053
5/17/13
Kainox VCS, Linox, Linox Smart, Vigila, Volta LeadsBiotronik, Inc.
Lake Oswego, OR 97035
Use a new maximum sterilization chamber load at the contract sterilizer for their marketed leads.
P980023/S055
5/29/13
Kainox VCS, Linox, Vigila, VoltaBiotronik, Inc.
Lake Oswega, OR 97035
A change in sterilization load configuration; 2) change in sterilization pre-conditioning; 3) sterilization injection parameter changes; and 4) change to the process challenge device.
P980035/S318
5/7/13
Advisa MRIMedtronic, Inc.
Mounds View, MN 55112
Seven previously approved manufacture changes for the devices. Those are: 1) update the CMOS IC Process Flow Changes at your supplier; 2) update the test software and hardware on the Teradyne Test Platform for M019 and M017 ICs; 3) add the High Temperature Monitor to High Power Lean Line; 4) update the Automated Assembly Equipment Controller (AAEC); 5) implement a new Cleaning process and a Curing Oven; 6) implement a manufacturing execution system version 7.9 at various internal suppliers and final device manufacturing locations; and 7) update to the Test System Software Shell.
P980035/S322
5/14/13
Advisa DR IPG, Advisa DR MRI IPGMedtronic, Inc.
Mounds View, MN 55112
Butted Contact etch time change for the M016 and M017 Integrated Circuits.
P980035/S323
5/23/13
Adapta/Versa/Sentia IPGMedtronic, Inc.
Mounds View, MN 55112
Use of a new sterilizer and aerator.
P980049/S082
5/3/13
Paradym VR and DR ICDsSorin CRM USA, Inc.
Arveda, CO
80004
Extending the use of a plasma cleaning step used during the micro-electronic assembly process.
P980050/S083
5/29/13
Transvene LeadMedtronic, Inc.
Mounds View, MN 55112
Update to the maximum sterilization load profile temperature.
P990025/S037
5/29/13
NaviStar, NaviStar RMT, EZ Steer Nay Catheters and BWI CablesBiosense Webster, Inc.
Diamond Bar, CA 91765
Addition of an alternate supplier for the extrusion and braiding process for the family of products.
P990075/S023
5/15/13
Mentor Saline-Filled Breast ImplantsMentor Worldwide LLC
Santa Barbara, CA 93111
Add an additional supplier of the diaphragm valve component used in the manufacture of the Mentor Saline-Filled Breast Implants.
P990081/S018
5/13/13
PATHWAY Anyi-HER-2/neu (4B5) Rabbit Monoclonal Primary AntibodyVentana Medical Systems, Inc.
Tucson, AZ
85755
Addition of a new supplier of Printed Circuit Board Assemblies used in the production of the BenchMark ULTRA and BenchMark XT instruments.
P000021/S025
5/28/13
Dimension Vista® TPSA Flex® Reagent CartridgeSiemens Healthcare Diagnostics Inc.
Newark DE
19714
Change the supplier for Dextran T110 from Sigma Adrich Fine Chemicals (SAFC) to Pharmacomos and to bring phthalocyanine manufacture in-house at the Siemens Healthcare Diagnostics, Newark, Delaware site and the scale-up of the sensibead concentrate production from 150g per lot size to 300g.
P000025/S069
5/29/13
Mi1000 MED-EL CONCERT Cochlear ImplantsMED-EL Elektro-Medizinische Geräte GmbH
Fürstenweg, Austria 77a
Additional supplier of the 16-Pin Feedthrough Assembly component which is used in the production of the Mi1000 MED-EL CONCERT Cochlear Implants.
P000036/S016
5/21/13
DermagraftShire Regenerative Medicine, Inc.
La Jolla, CA
92121
Change in the software used to regulate the Dermagraft cell culture process.
P000036/S017
5/23/13
DermagraftShire Regenerative Medicine, Inc.
La Jolla, CA
92121
Qualification of additional seeding vessels, and proposed a change in the type of material used for the tubing and manifold assembly connector fittings.
P000036/S018
5/21/13
DermagraftShire Regenerative Medicine, Inc.
La Jolla, CA
92121
Addition of a Laminar Flow Hood, Freezer Replacement (Single to Dual compressor), Distribution Freezer transfer to Warehouse for Sample Storage, and an addition of a Liquid Nitrogen Storage Freezer.
P010015/S199
5/14/13
Consulta CRT-P, Syncra CRT-PMedtronic, Inc.
Mounds View, MN 55112
Butted Contact etch time change for the M016 and M017 Integrated Circuits.
P010015/S200
5/29/13
Attain Bipolar OTW Lead, Left Ventricular Pacing LeadMedtronic, Inc.
Mounds View, MN 55112
Update to the maximum sterilization load profile temperature.
P010031/S370
5/3/13
Concerto, Consulta, Insync III Marquis, and InSync Maximo
CRT-D families: Concerto II, Brava, Viva S, Viva XT, Maximo II, Protecta, and Protecta XT ICD Families
Medtronic, Inc.
Mounds View, MN 55112
Implementation of an updated acceptance criterion for evaluation of insulator materials used in the manufacture of the subject ICDs and CRT-D devices.
P010031/S371
5/7/13
Brava CRT-D, Viva S CRT-D, Viva XT CRT-DMedtronic, Inc.
Mounds View, MN 55112
Seven previously approved manufacture changes for the devices. Those are: 1) update the CMOS IC Process Flow Changes at your supplier; 2) update the test software and hardware on the Teradyne Test Platform for M019 and M017 ICs; 3) add the High Temperature Monitor to High Power Lean Line; 4) update the Automated Assembly Equipment Controller (AAEC); 5) implement a new Cleaning process and a Curing Oven; 6) implement a manufacturing execution system version 7.9 at various internal suppliers and final device manufacturing locations; and 7) update to the Test System Software Shell.
P010031/S374
5/14/13
Brava CRT-D, Concerto II CRT-D, Consulta ICD, Maximo II CRT-D,
Protecta CRT-D, Protecta XT
CRT-D, Viva S CRT-D, Viva XT CRT-D
Medtronic, Inc.
Mounds View, MN 55112
Butted Contact etch time change for the M016 and M017 Integrated Circuits.
P010031/S375
5/22/13
Brava CRT-D, Concerto II CRT-D, Consulta ICD, Maximo II CRT-D, Protecta CRT-D, Protecta XT CRT-D, Viva S CRT-D, Viva XT CRT-DMedtronic, Inc.
Mounds View, MN 55112
 
Second source supplier for a thick film chip resistor.
P010068/S034
5/29/13
Celsius DS, NaviStar DS, NaviStar RMT DS, EZ Steer Nav DS CathetersBiosense Webster, Inc.
Diamond Bar, CA 91765
Addition of an alternate supplier for the extrusion and braiding process for the family of products.
P020004/S081
5/2/13
GORE® EXCLUDER® AAA EndoprosthesisW.L. Gore and Associates
Flagstaff, AZ
86004
Alternate FEP film supplier and a change from in-process testing to the raw material testing for certain tests performed by the new qualified supplier.
P020027/S020
5/28/13
Dimension Vista® FPSA Flex® Reagent CartridgeSiemens Healthcare Diagnostics Inc.
Newark DE
19714
Change the supplier for Dextran T110 from Sigma Adrich Fine Chemicals (SAFC) to Pharmacomos and to bring phthalocyanine manufacture in-house at the Siemens Healthcare Diagnostics, Newark, Delaware site and the scale-up of the sensibead concentrate production from 150g per lot size to 300g.
P020055/S007
5/13/13
PATHWAY Anti-c-KIT (9.7) Rabbit Monoclonal Primary AntibodyVentana Medical Systems, Inc.
Tucson, AZ
85755
Addition of a new supplier of Printed Circuit Board Assemblies used in the production of the BenchMark ULTRA and BenchMark XT instruments.
P030009/S064
5/8/13
Integrity Coronary Stent SystemMedtronic Vascular, Inc.
Santa Rosa, CA 95403
Change to the in-process sampling requirements of several extruded tubing components.
P030017/S161
5/1/13
Precision and Precision Spectra Spinal Cord Stimulator SystemsBoston Scientific Corporation
Valencia, CA
91355
Manufacturing facility move for the packaging pouch supplier.
P030031/S052
5/29/13
Celsius ThermoCool, Celsius RMT ThermoCool CathetersBiosense Webster, Inc.
Diamond Bar, CA 91765
Addition of an alternate supplier for the extrusion and braiding process for the family of products.
P030035/S110
5/14/13
Frontier, Frontier II, AnthemSt. Jude Medical
Sylmar, CA
91342
Alternate sterilization cycle at the Puerto Rico manufacturing facility.
P030035/S111
5/30/13
Frontier, Frontier II, Anthem family of CRT-P DevicesSt. Jude Medical
Sylmar, CA
91342
Alternate assembly process for attaching the X-Ray Tag to the hybrid.
P030036/S057
5/29/13
SelectSecure LeadMedtronic, Inc.
Mounds View, MN 55112
Update to the maximum sterilization load profile temperature.
P030054/S245
5/14/13
Epic HF, Epic + HF, Epic II HF, Epic II+ HF, Atlas HF, Atlas + HF, Atlas II HF, Atlas II+ HF, Promote,
Promote +, Promote HF, Promote Accel, Unify, Unify Assura, Promote Q, Promote Quadra, Quadra Assura, Unify Quadra
St. Jude Medical
Sylmar, CA
91342
Alternate sterilization cycle at the Puerto Rico manufacturing facility.
P040020/S047
5/21/13
AcrySof ReSTOR Intraocular LensesAlcon Research Ltd.
Fort Worth, TX 76134
Relocate packaging and labeling equipment.
P040027/S029
5/2/13
GORE® VIATORR® TIPS EndoprosthesisW.L. Gore and Associates
Flagstaff, AZ
86004
Alternate FEP film supplier and a change from in-process testing to the raw material testing for certain tests performed by the new qualified supplier.
P040036/S036
5/29/13
NaviStar-, Navistar RMT-, EZ Steer- ThermoCool CathetersBiosense Webster, Inc.
Diamond Bar, CA 91765
Addition of an alternate supplier for the extrusion and braiding process for the family of products.
P040037/S048
5/2/13
GORE® VIABAHN® EndoprosthesisW.L. Gore and Associates
Flagstaff, AZ
86004
Alternate FEP film supplier and a change from in-process testing to the raw material testing for certain tests performed by the new qualified supplier.
P040037/S049
5/14/13
GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive SurfaceW.L. Gore and Associates, Inc. Flagstaff, AZ
86001
Automate selection of raw material/ components during device/catheter assembly.
P040043/S052
5/2/13
GORE® TAG® Thoracic EndoprosthesisW.L. Gore and Associates
Flagstaff, AZ
86004
Alternate FEP film supplier and a change from in-process testing to the raw material testing for certain tests performed by the new qualified supplier.
P050023/S064
5/17/13
Corox OTW 75 UP Steroid, Corox OTW 85 UP Steroid LeadsBiotronik, Inc.
Lake Oswego, OR 97035
Use a new maximum sterilization chamber load at the contract sterilizer for their marketed leads.
P050023/S065
5/29/13
Ilesto, Iforia, LumaxBiotronik, Inc.
Lake Oswega, OR 97035
A change in sterilization load configuration; 2) change in sterilization pre-conditioning; 3) sterilization injection parameter changes; and 4) change to the process challenge device.
P050028/S031
5/7/13
COBAS® TaqMan HBV Test For Use With The High Pure System and
COBAS® AmpliPrep/ COBAS® TaqMan® HBV Test version 2.0
Roche Molecular Systems, Inc.
Pleasanton, CA 94588
Change for an optimization of the kit QC functional testing calculation method.
P050037/S037
5/30/13
Radiesse Injectable ImplantMerz Aesthetics, Inc.
Franksville, WI 53126
Addition of a new syringe component supplier.
P050042/S024
5/22/13
ARCHITECT Anti-HCVAbbott Laboratories
Abbott Park, IL 60064
Change to a supplier quality control test method and acceptance specifications for an incoming bulk material used in the manufacture of the ARCHITECT Anti-HCV test kit.
P050052/S040
5/30/13
Radiesse Injectable ImplantMerz Aesthetics, Inc.
Franksville, WI 53126
Addition of a new syringe component supplier.
P060002/S032
5/29/13
Bard® FLAIR® Endovascular Stent GraftBard Peripheral Vascular, Inc.
Tempe, AZ
85281
Update the bond peel inspection.
P060027/S050
5/3/13
Paradym CRT-D and Paradym RF CRT-DSorin CRM USA, Inc.
Arveda, CO
80004
Extending the use of a plasma cleaning step used during the micro-electronic assembly process.
P060033/S074
5/8/13
Endeavor Sprint Zotarolimus-Eluting Coronary Stent
System
Medtronic Vascular, Inc.
Santa Rosa, CA 95403
Change to the in-process sampling requirements of several extruded tubing components.
P060033/S076
5/29/13
Endeavor Sprint Zotarolimus-Eluting Coronary Stent
System
Medtronic Vascular, Inc.
Santa Rosa, CA 95403
Alternate analytical testing supplier.
P060039/S056
5/29/13
Attain StarFix LeadMedtronic, Inc.
Mounds View, MN 55112
Update to the maximum sterilization load profile temperature.
P070007/S037
5/2/13
Talent AAA Stent Graft SystemMedtronic Vascular
Santa Rosa, CA 95403
Add manufacturing steps related to the stent ring and markers to an existing internal manufacturing facility.
P070008/S042
5/17/13
Celerity and Corox LeadsBiotronik, Inc.
Lake Oswego, OR 97035
Use a new maximum sterilization chamber load at the contract sterilizer for their marketed leads.
P070008/S043
5/29/13
Stratos, Evia HF, Entovis HF, Celerity, CoroxBiotronik, Inc.
Lake Oswega, OR 97035
A change in sterilization load configuration; 2) change in sterilization pre-conditioning; 3) sterilization injection parameter changes; and 4) change to the process challenge device.
P070027/S036
5/2/13
Talent Thoracic
Stent Graft System
Medtronic Vascular
Santa Rosa, CA 95403
Add manufacturing steps related to the stent ring and markers to an existing internal manufacturing facility.
P080006/S053
5/29/13
Attain Ability LeadMedtronic, Inc.
Mounds View, MN 55112
Update to the maximum sterilization load profile temperature.
P080011/S023
5/7/13
CooperVision Biofinity (comfilcon A) Soft (Hydrophilic) Extended-Wear Contact LensesCooperVision, Incorporated
Pleasanton, CA 94588
Minor modification to the manufacturing process.
P080026/S007
5/28/13
Abbott RealTime HBVAbbott Molecular Inc.
Des Plaines, IL 60018
Change to the sampling plan for the reagent vial filling procedure for both devices.
P080030/S008
5/1/13
iStent Trabecular Micro-Bypass Stent SystemGlaukos Corporation
Laguna Hills, CA 92653
Change QC testing of the iStent Trabecular Micro-Bypass Stent System.
P090006/S010
5/22/13
Complete SE Vascular Stent SystemMedtronic Vascular
Santa Rosa, CA 95403
Alternate site for the packaging pouch supplier.
P090013/S092
5/14/13
CapSureFix MRI Pacemaker LeadMedtronic
Mounds View, MN 55112
Replacing the test used for in-process monitoring of an inner insulation parameter.
P090013/S095
5/14/13
Revo MRI IPGMedtronic, Inc.
Mounds View, MN 55112
Butted Contact etch time change for the M016 and M017 Integrated Circuits.
P090013/S096
5/23/13
CapSureFix MRI SureScan LeadMedtronic, Inc.
Mounds View, MN 55112
Use of a new sterilizer and aerator.
P090013/S097
5/29/13
CapSureFix MRI LeadMedtronic, Inc.
Mounds View, MN 55112
Update to the maximum sterilization load profile temperature.
P100013/S009
5/9/13
ExoSeal Vascular Closure DeviceCordis Corporation
Bridgewater, NJ 08807
Change in the processing of three components from single cavity mold to multi cavity molds for the ExoSeal Vascular Closure Device.
P100017/S006
5/28/13
Abbott RealTime HCVAbbott Molecular Inc.
Des Plaines, IL 60018
Change to the sampling plan for the reagent vial filling procedure for both devices.
P100018/S007
5/9/13
Pipeline Embolization DeviceMicro Therapeutics, Inc. d.b.a. ev3 Neurovascular
Irvine, CA
92618
Manufacturing process change for the protective coil of the Pipeline Embolization Device delivery system.
P100021/S025
5/2/13
Endurant Stent Graft SystemMedtronic Vascular
Santa Rosa, CA 95403
Add manufacturing steps related to the stent ring and markers to an existing internal manufacturing facility.
P100027/S008
5/13/13
INFORM HER2 Dual ISH DNA Probe CocktailVentana Medical Systems, Inc.
Tucson, AZ
85755
Addition of a new supplier of Printed Circuit Board Assemblies used in the production of the BenchMark ULTRA and BenchMark XT instruments.
P100027/S010
5/29/13
INFORM HER2 Dual ISH DNA Probe CocktailVentana Medical Systems, Inc.
Tucson, AZ
85755
Qualification of a new supplier for a raw material that is used in the manufacture of the detection kit associated with the INFORM HER-2 Dual ISH DNA Probe Cocktail. As part of this change in raw material, a change in the cell media used to grow the anti-DNP antibody is also being implemented.
P100040/S011
5/2/13
Valiant Thoracic Stent Graft SystemMedtronic Vascular
Santa Rosa, CA 95403
Add manufacturing steps related to the stent ring and markers to an existing internal manufacturing facility.
P110007/S004
5/8/13
AMO Healon EndoCoat Ophthalmic
Viscosurgical Device (OVD), (3% Sodium Hyaluronate)
Abbott Medical Optics, Inc.
Santa Ana, CA 92705
Transfer the preparation of the working cell bank to Lifecore Biomedical.
P110013/S010
5/8/13
Resolute Integrity Zotarolimus-Eluting Coronary Stent SystemMedtronic Vascular, Inc.
Santa Rosa, CA 95403
Change to the in-process sampling requirements of several extruded tubing components.
P110013/S013
5/29/13
Endeavor Sprint Zotarolimus-Eluting Coronary Stent SystemMedtronic Vascular, Inc.
Santa Rosa, CA 95403
Alternate analytical testing supplier.
P110019/S044
5/21/13
XIENCE XPEDITION™ Everolimus Eluting Coronary Stent System (XIENCE XPEDITION, XIENCE XPEDITION Small Vessel [SV], and XIENCE XPEDITION LL) in the RX PlatformAbbott Vascular
Temecula, CA
92590
Change to the stent delivery system bonding process.
P110035/S013
5/31/13
Epic Vascular Self-Expanding Stent SystemBoston Scientific Corporation
Maple Grove, MN 55311
Add in-process controls for a component bonding step.
P110042/S008
5/14/13
Subcutaneous Implantable Defibrillator (S-ICD) SystemBoston Scientific Corporation
St. Paul, MN
55112
Use a new Receiving Inspection Workbook Tool.

Summary of PMA Originals Under Review
Total Under Review: 55                                                        
Total Active: 22                                                                     
Total On Hold: 33                                                                                          

Summary of PMA Supplements Under Review
Total Under Review: 655                                                      
Total Active: 481                                           
Total On Hold: 174                                                                                        

Summary of All PMA Submissions Received
Originals: 8                                                                 
Supplements: 81                                                                     

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 72                                                      
Number of Denials: 0                                                 
Average Days Fr Receipt to Decision (Total Time): 127.9      
FDA Time: 99.5 Days      MFR Time: 28.4 Days