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U.S. Department of Health and Human Services

Medical Devices

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November 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
P090012
11/1/11
MelaFind®MELA Sciences, Inc.
Irving, NY
10533
Approval for the MelaFind device. MelaFind is intended for use on clinically atypical cutaneous pigmented lesions with one or more clinical or historical characteristics of melanoma, excluding those with a clinical diagnosis of melanoma or likely melanoma. MelaFind is designed to be used when a dermatologist chooses to obtain additional information for a decision to biopsy. MelaFind should NOT be used to confirm a clinical diagnosis of melanoma.
MelaFind is only for use by physicians trained in the clinical diagnosis and management of skin cancer (i.e., dermatologists) who have also successfully completed a training program in the appropriate use of MelaFind.
The MelaFind result is one element of the overall clinical assessment. MelaFind positive lesions (which may include malignant melanoma, melanoma in situ, high grade dysplastic nevi and atypical melanocytic proliferation/hyper-plasia) should be considered for biopsy; the biopsy decision of a MelaFind negative lesion should be based on the remainder of the entire clinical context. Lesions that are "non-evaluable" by MelaFind should be carefully re-evaluated for biopsy.
MelaFind is indicated only for use on lesions with a diameter between 2 mm and 22 mm, lesions that are accessible by the MelaFind imager, lesions that are sufficiently pigmented (i.e. not for use on non-pigmented or skin-colored lesions), lesions that do not contain a scar or fibrosis consistent with previous trauma, lesions where the skin is intact (Le., non-ulcerated or non-bleeding lesions), lesions greater than 1 cm away from the eye, lesions which do not contain foreign matter, and lesions not on special anatomic sites (ie., not for use on acral, palmar, plantar, mucosal, or subungual areas). MelaFind is not designed to detect pigmented non-melanoma skin cancers, so the dermatologist should rely on clinical experience to diagnose such lesions.
P090016
11/14/11
BELOTERO BalanceMerz Pharmaceuticals, LLC
Greensboro, NC
27410
Approval for BELOTERO Balance. This device is indicated for injection into the mid-to-deep dermis for correction of moderate-to-severe facial wrinkles and folds such as nasolabial folds.
P100024
11/30/11
HER2 CISH pharmDx™ KitDako Denmark A/S
Glostrup, Denmark
DK-2600
 

Approval for the HER2 CISH pharmDx™ Kit. This device is indicated for:

HER2 CISH pharmDx™ Kit is intended for dual-color chromogenic visualization of signals achieved with directly labeled in situ hybridization probes targeting the HER2 gene and centromeric region of chromosome 17. The Kit is designed to quantitatively determine HER2 gene status in formalin-fixed, paraffin-embedded breast cancer tissue specimens.

Red and blue chromogenic signals are generated on the same tissue section for evaluation under bright field microscopy. The CISH procedure is automated using Dako Autostainer instruments.

HER2 CISH pharmDx™ Kit is indicated as an aid in the assessment of patients for whom Herceptin™ (trastuzumab) treatment is being considered. Results from the HER2 CISH pharmDx™ Kit are intended for use as an adjunct to the clinicopathologic information currently used for estimating prognosis in stage II, node-positive breast cancer patients.

P100041
11/2/11
Edwards SAPIEN™ Transcatheter Heart ValveEdwards Lifesciences, LLC
Irvine, CA
92614
Approval for the
SAPIEN™ Transcatheter Heart Valve, model 9000TFX, sizes 23mm and 26mm and accessories.
This device is indicated for transfemoral delivery in patients with severe symptomatic native aortic valve stenosis who have been determined by a cardiac surgeon to be inoperable for open aortic valve replacement and in whom existing co-morbidities would not preclude the expected benefit from correction of the aortic stenosis.
P110010
11/22/11
PROMUS® Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent
System (Monorail™ and Over-The-Wire)
Boston Scientific Corporation
Maple Grove, MN
55311
Approval for the PROMUS® Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System. This device is indicated for improving luminal diameter in patients with symptomatic heart disease due to de novo lesions in native coronary arteries ≥ 2.25 mm to ≤ 4.00 mm in diameter in lesions ≤ 28 mm in length.
P110019
11/1/11
XIENCE PRIME and XIENCE PRIME LL Everolimus Eluting Coronary Stent SystemAbbott Vascular, Inc.
Santa Clara, CA
95054
Approval for the XIENCE PRIME and XIENCE PRIME LL Everolimus Eluting Coronary Stent System. This device is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (length ≤ 32 mm) with reference vessel diameters of ≥ 2.25 mm to ≤ 4.25 mm.

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
P810002/S077
11/10/11
135-Day
St. Jude Mechanical Heart ValveSt. Jude Medical, Inc.
St. Paul, MN
55117
Approval for eliminating the use of one method for coating thickness image capture and replace it with a new method.
P820003/S113
11/17/11
Real-Time
Various Families of Pasys, Spectrax, Symbios and SynergystMedtronic, Inc.
Mounds View, MN
55112
Approval for an update to the operating system software for the CareLink Programmer associated with Medtronic pacemaker, implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) devices approved under the referenced PMA.
P830055/S106
11/2311
180-Day
LCS Total Knee SystemDePuy Orthopaedics, Inc. Warsaw, IN
46581
Approval to manufacture the subject components from GUR 1020 polyethylene with an antioxidant (AOX™), to change the packaging components and materials, and to request approval of a shelf-life testing protocol for the subject P.F.C Sigma RP Curved and Stabilized Tibial Inserts.
P830061/S066
11/18/11
135-Day
CapSure, Vitatron Crystalline, and Vitatron Excellence PS+ LeadsMedtronic, Inc.
Mounds View, MN
55112
Approval for updates to the sterile packaging assembly process for new and existing sealer equipment.
P840001/S184
11/9/11
135-Day
RestorePrime® Implantable Neurostimulator (INS), PrimeAdvanced® INS, Restore® INS, RestoreUltra® INS, RestoreAdvanced® INS and External Neurostimulator
 
Medtronic Neuromodulation
Minneapolis, MN
55432
Approval for a modification to a cleaning process for hybrid components.
P840001/S185
11/3/11
180-Day
RestoreSensor™ Rechargeable Implantable Neurostimulation SystemMedtronic Neuromodulation
Minneapolis, MN
55432
Approval for the RestoreSensor™ Rechargeable Implantable Neurostimulation
System. The device, as modified, will be marketed under the trade name RestoreSensor™
Rechargeable Implantable Neurostimulation System and is indicated for spinal cord stimulation
(SCS) as an aid in the management of chronic, intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following conditions:
1) Failed Back Syndrome (FBS) or low back syndrome or failed back;
2) Radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or
herniated disk;
3) Postlaminectomy pain; 4) Multiple back operations;
5) Unsuccessful disk surgery;
6) Degenerative Disk Disease (DDD)/herniated disk pain refractory to conservative and
surgical interventions;
5) Peripheral causalgia;
6) Epidural fibrosis;
7) Arachnoiditis or lumbar adhesive arachnoiditis; and
8) Complex Regional Pain Syndrome (CRPS), Reflex Sympathetic Dystrophy (RSD), or causalgia.
P850051/S078
11/17/11
Real-Time
Vitatron Legacy, Prevail, Premier and Various Families of Activitrax, Legend, MinixMedtronic, Inc.
Mounds View, MN
55112
Approval for an update to the operating system software for the CareLink Programmer associated with Medtronic pacemaker, implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) devices approved under the referenced PMA.
P850089/S078
11/18/11
135-Day
CapSure, CapSure Z Novus, Vitatron Excellence SS+ and Vitatron Impulse II LeadsMedtronic, Inc.
Mounds View, MN
55112
Approval for updates to the sterile packaging assembly process for new and existing sealer equipment.
P860004/S150
11/9/11
135-Day
Synchromed® PumpMedtronic Neuromodulation
Minneapolis, MN
55432
Approval for a modification to a cleaning process for hybrid components.
P860004/S159
11/10/11
Real-Time
SyncroMed II Implantable Infusion PumpMedtronic Neuromodulation
Minneapolis, MN
55432
Approval for minor changes to the dimensional specifications of the SynchroMed II pump tube assembly component.
P890003/S181
11/9/11
180-day
Carelink Monitor,
CardioSight® Reader, DDMA
Medtronic, Inc.
Mounds View, MN
55112
Approval for the Protecta™ XT CRT-D, D314TRM and Protecta™ CRT-D
D334TRM Implantable Cardioverter Defibrillators with Cardiac Resynchronization, Protecta™
XT DR D314DRM and Protecta™ DR D334DRM Implantable Cardioverter Defibrillators,
Model SW009 Application Software vl.0, Carelink Monitor Model 2490C upgrade, CardioSight
Reader Model 2020A upgrade and Model 2491 DDMA upgrade.
P890003/S229
11/18/11
135-Day
CapSure, CapSure Model LeadsMedtronic, Inc.
Mounds View, MN
55112
Approval for updates to the sterile packaging assembly process for new and existing sealer equipment.
P890003/S235
11/17/11
Real-Time
Prodigy, Minuet, Synergyst II and Various Families of Elite, Preva, Thera and Vitatron LegacyMedtronic, Inc.
Mounds View, MN
55112
Approval for an update to the operating system software for the CareLink Programmer associated with Medtronic pacemaker, implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) devices approved under the referenced PMA.
P890047/S022
11/3/11
180-Day
PROVISC® Ophthalmic Viscosurgical Device (OVD)Alcon Research, Ltd.
Fort Worth, TX
76134
Approval for an improved buffer formulation and latex-free packaging configuration for the device.
P900061/S110
11/17/11
Real-Time
Gem, PCD and Various Families of JewelMedtronic, Inc.
Mounds View, MN
55112
Approval for an update to the operating system software for the CareLink Programmer associated with Medtronic pacemaker, implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) devices approved under the referenced PMA.
P910001/S040
11/18/11
Spectranetics Coronary Atherectomy (ELCA) CatheterSpectranetics Corporation
Colorado Springs, CO
80921
Approval for a sterilization site located at CaridianBCT Sterilization Services in Lakewood, Colorado.
P910023/S276
11/1/11
Real-Time
Promote and Unify Families of Pulse GeneratorsSt. Jude Medical
Sylmar, CA
91392
Approval for the introduction of the IS4/DF4 Port plug accessory model AC-IS4PP for use with all SJM DF4 or IS4 header ports.
P920015/S078
11/18/11
135-Day
Sprint Quattro, Subcutaneous Lead and Transvene SVC LeadsMedtronic, Inc.
Mounds View, MN
55112
Approval for updates to the sterile packaging assembly process for new and existing sealer equipment.
P920023/S023
11/23/11
180-Day
UroLume® EndoprosthesisAmerican Medical Systems
Minnetonka, MN
55343
Approval for modification of the device labeling to include the results of post approval studies.
P920047/S049
11/17/11
Real-Time
Blazer II, Blazer II HTD Cardiac Ablation CatheterBoston Scientific Corporation
San Jose, CA
95134
Approval for the internal glue flap and the carton end closure changes to the packaging design.
P930022/S013
11/17/11
Real-Time
Legend PlusMedtronic, Inc.
Mounds View, MN
55112
Approval for an update to the operating system software for the CareLink Programmer associated with Medtronic pacemaker, implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) devices approved under the referenced PMA.
P930039/S056
11/18/11
135-Day
CapSure, SureFix and Vitatron Crystalline ActFix LeadsMedtronic, Inc.
Mounds View, MN
55112
Approval for updates to the sterile packaging assembly process for new and existing sealer equipment.
P940035/S006
11/15/11
180-Day
NMP22® BladderChek® Test KitAlere Scarborough, Inc.
Scarborough, ME
04074
Approval for manufacturing site located at Alere Scarborough, Inc. in Scarborough, Maine.
P950009/S013
11/10/11
Real-Time
BD FocalPoint™ Slide ProfilerTRIPATH Imaging, Inc.
Durham, NC
27703
Approval for software changes to the BD FocalPoint™ Slide Profiler from the current production version APPS 3.4.1a to APPS 3.5.0.
P960009/S115
11/9/11
135-Day
Activa® PC INS, Activa RC INS and External NeurostimulatorMedtronic Neuromodulation
Minneapolis, MN
55432
Approval for a modification to a cleaning process for hybrid components.
P960013/S066
11/1/11
180-Day
Tendril and Pacemaker LeadsSt. Jude Medical
Sylmar, CA
91342
Approval for three additional lead lengths of 65, 85 and 100 cm in the Tendril STS pacemaker leads.
P960040/S235
11/17/11
180-Day
INCEPTA ICD, ENERGEN ICD, PUNCTUA ICD, TELIGENBoston Scientific Corporation
St. Paul, MN
55112
Approval for INCEPTA, ENERGEN. PUNCTUA and TELIGEN ICD Models and the INCEPTA, ENERGEN. PUNCTUA and COGNIS CRT-D Models and PRM Software
Application Model 2868 and Pulse Generator Software. The devices as modified will be
marketed under the trade names INCEPTA, ENERGEN, PUNCTUA, TELIGEN AND COGNIS
ICD and CRT-D Models and are indicated to provide ventricular antitachycardia pacing (ATP)
and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias
or for patients with heart failure who receive stable optimal pharmacological therapy: Moderate
to severe heart failure (NYHA Class III-IV) with EF ≤ 35% and QRS duration ≥ 120 ms and Left Bundle Branch Block (LBBB) with QRS ≥ 130 ms, EF ≤ 30%, and mild (NYHA Class II) ischemic or nonischemic heart failure or asymptomatic (NYHA Class 1) ischemic heart failure.
P960042/S023
11/18/11
180-Day
SLS II Laser SheathSpectranetics Corporation
Colorado Springs, CO
80921
Approval for a sterilization site located at CaridianBCT Sterilization Services in Lakewood, Colorado.
P960058/S089
11/17/11
180-Day
Auria Harmony HiResolution Bionic Ear System Neptune, AquaMic and SoundWave 2.1Advanced Bionics, LLC
Sylmar, CA
91342
Approval for a new off-the-ear sound processor called Neptune and its associated accessories. The Neptune processor, when used with the new AquaMic headpiece, is waterproof. In addition, a new version of SoundWave Professional Software Suite (SoundWave 2.1) is included in the supplement.
P970004/S112
11/9/11
135-Day
InterStim® II INSMedtronic Neuromodulation
Minneapolis, MN
55432
Approval for a modification to a cleaning process for hybrid components.
P970012/S089
11/17/11
Real-Time
Kappa 400 IPGMedtronic, Inc.
Mounds View, MN
55112
Approval for an update to the operating system software for the CareLink Programmer associated with Medtronic pacemaker, implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) devices approved under the referenced PMA.
P970051/S075
11/29/11
135-Day
Nucleus Cochlear Implant SystemCochlear Americas
Centennial, CO
80111
Approval for a change in tolerance to the Feedthrough Comb Sintered Powder Injection Molding.
P970051/S087
11/4/11
Real-Time
Nucleus 24 Cochlear Implant SystemCochlear Americas
Centennial, CO
80111
Approval to modify the layout of the non-hermetic region of the feedthrough assembly on the currently approved CI24RE implant of the device.
P980003/S031
11/17/11
Real-Time
Chilli II Cooled Ablation System & Sterile CablesBoston Scientific Corporation
San Jose, CA
95134
Approval for the internal glue flap and the carton end closure changes to the packaging design.
P980016/S218
11/9/11
180-Day
Protecta™ and Protecta™ DR
Implantable Cardioverter Defibrillators
Model SW009 Application Software vl.0 Systems
Medtronic, Inc.
Mounds View, MN
55112
Approval for the Protecta™ XT CRT-D, D314TRM and Protecta™ CRT-D
D334TRM Implantable Cardioverter Defibrillators with Cardiac Resynchronization, Protecta™
XT DR D314DRM and Protecta™ DR D334DRM Implantable Cardioverter Defibrillators,
Model SW009 Application Software vl.0, Carelink Monitor Model 2490C upgrade. CardioSight
Reader Model 2020A upgrade and Model 2491 DDMA upgrade.
P980016/S305
11/10/11
135-Day
Maximo II, Protecta, Protecta XT, Secura, and Virtuoso II
 
Medtronic, Inc.
Mounds View, MN
55112
Approval for addition of a cleaning process at the supplier.
P980016/S323
11/17/11
Real-Time
Entrust, Intrinsic, Marquis, Onyx, Secura and Various Families of Gem, Maximo, Protecta and VirtuosoMedtronic, Inc.
Mounds View, MN
55112
Approval for an update to the operating system software for the CareLink Programmer associated with Medtronic pacemaker, implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) devices approved under the referenced PMA.
P980035/S242
11/17/11
Real-Time
Adapta, Advisa, AT500, EnPulse, EnRhythm, Relia, Sensia, Sigma, Versa and Various Families of KappaMedtronic, Inc.
Mounds View, MN
55112
Approval for an update to the operating system software for the CareLink Programmer associated with Medtronic pacemaker, implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) devices approved under the referenced PMA.
P980035/S244
11/1/11
Real-Time
Adapta, Versa, Sensia and Relia IPG DevicesMedtronic, Inc.
Mounds View, MN
55112
Approval for updates to Medtronic’s Adapta/ Versa/Sensia and Relia Implantable Pulse Generator (IPG) Application Software to correct the battery measurement lock-up condition.
P980035/S245
11/22/11
Real-Time
Advisa DR A4DR01 Implantable Pulse GeneratorMedtronic, Inc.
Mounds View, MN
55112
Approval for an update to the hybrid design and protection integrated circuits approved under the referenced PMA.
P980037/S038
11/2/11
180-Day
AngioJet® Rheolytic™ Thrombectomy SystemMEDRAD Interventional /Possis
Minneapolis, MN
55433
Approval for a change of the Angiojet Ultra System Console software to version V2.0.14.
P980050/S062
11/18/11
135-Day
Transvene CS/SVC LeadsMedtronic, Inc.
Mounds View, MN
55112
Approval for updates to the sterile packaging assembly process for new and existing sealer equipment.
P980050/S067
11/17/11
Real-Time
Jewel AF, GEM III ATMedtronic, Inc.
Mounds View, MN
55112
Approval for an update to the operating system software for the CareLink Programmer associated with Medtronic pacemaker, implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) devices approved under the referenced PMA.
P990001/S096
11/17/11
Real-Time
Diva IPG Family, Dema IPG Family and Various C-Series and T-Series DevicesMedtronic, Inc.
Mounds View, MN
55112
Approval for an update to the operating system software for the CareLink Programmer associated with Medtronic pacemaker, implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) devices approved under the referenced PMA.
P990012/S010
11/16/11
135-Day
Elecsys HBsAg ImmunoassayRoche Professional Diagnostics
Indianapolis, IN
46250
Approval for the in-process test method for determination of particle concentration of Elecsys coated microparticle (beads).
P990012/S011
11/17/11
135-Day
Elecsys HBsAg ImmunoassayRoche Diagnostics
Indianapolis, IN
46250
Approval for changes to the manufacturing procedure for the bead coating process of the intermediate storage form of Elecys coated microparticles.
P000006/S027
11/16/11
Real-Time
Titan Inflatable Penile ProsthesisColoplast Corporation
Minneapolis, MN
55411
Approval to implement a new mold for the One-Touch Release (OTR) Pump body and associated changes to several dimensional specifications.
P000008/S22
11/18/11
180-Day
LAP-BAND® Adjustable Gastric Banding SystemAllergan
Goleta, CA
93117
Approval of the post-approval study protocol.
P000014/S024
11/10/11
Real-Time
VITROS Immunodiagnostic Products Anti-HBs Reagent Pack and CalibratorOrtho-Clinical Diagnostics, Inc.
Rochester, NY
14646
Approval for the change in on-instrument storage of patient samples from 2 hours to 3 hours.
P000018/S045
11/4/11
135-Day
Novoste Beta-Cath SystemBest Vascular, Inc.
Norcross, GA
30093
Approval for changing lubing suppliers.
P000021/S020
11/23/11
180-Day
Dimension Vista® 500 SystemSiemens Healthcare Diagnostics, Inc.
Newark, DE
19714
Approval for the Dimension Vista® TPSA Flex® reagent cartridge for use on the Dimension Vista® 500 System.
P000032/S037
11/3/11
180-Day
Her Option Cryoablation Therapy SystemCooperSurgical, Inc.
Trumbull, CT
06611
Approval for manufacturing sites located at CooperSurgical, Inc. in Trumbull, Connecticut and Lone Star Medical Products in Stafford, Texas.
P000041/S010
11/8/11
180-Day
OnGuard 5.2.1Riverain Medical
Miamisburg, OH
45342
Approval for the OnGuard 5.2.1 computer aided detection software.
P000044/S028
11/10/11
Real-Time
VITROS Immunodiagnostic Products HBsAg Reagent Pack and Calibrator HBsAg Confirmatory KitOrtho-Clinical Diagnostics, Inc.
Rochester, NY
14646
Approval for the change in on-instrument storage of patient samples from 2 hours to 3 hours.
P010012/S255
11/17/11
180-Day
INCEPTA CRT-D, ENERGEN CRT-D, PUNCTUA CRT-D, COGNISBoston Scientific Corporation
St. Paul, MN
55112
Approval for INCEPTA, ENERGEN. PUNCTUA and TELIGEN ICD Models and the INCEPTA, ENERGEN. PUNCTUA and COGNIS CRT-D Models and PRM Software
Application Model 2868 and Pulse Generator Software. The devices as modified will be
marketed under the trade names INCEPTA, ENERGEN, PUNCTUA, TELIGEN AND COGNIS
ICD and CRT-D Models and are indicated to provide ventricular antitachycardia pacing (ATP)
and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias
or for patients with heart failure who receive stable optimal pharmacological therapy: Moderate
to severe heart failure (NYHA Class III-IV) with EF ≤ 35% and QRS duration ≥ 120 ms and Left Bundle Branch Block (LBBB) with QRS ≥ 130 ms, EF ≤ 30%, and mild (NYHA Class II) ischemic or nonischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure.
P010015/S129
11/18/11
135-Day
Attain LeadsMedtronic, Inc.
Mounds View, MN
55112
Approval for updates to the sterile packaging assembly process for new and existing sealer equipment.
P010015/S139
11/17/11
Real-Time
Consulta CRT-P, Syncra CRT-P, InSync/InSync IIIMedtronic, Inc.
Mounds View, MN
55112
Approval for an update to the operating system software for the CareLink Programmer associated with Medtronic pacemaker, implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) devices approved under the referenced PMA.
P010019/S025
11/2/11
180-Day
AIR OPTIX® NIGHT & DAY® AQUA (lotrafilcon A) soft contact lensesCIBA VISION Corporation
Duluth, GA
30097
Approval for a trade name change to the spherical (lotrafilcon A) soft contact lenses with wetting agent (l % Copolymer 845) in package saline, and the addition of descriptive text for symbols appearing on the cartons, except the Rx
symbol used for "prescription use," as well as the trade name changes to all the lotrafilcon A lens designs. The device, as modified, will be marketed under the following trade names: Spherical - AIR OPTIX® NIGHT & DAY® AQUA; Toric - AIR OPTIX® NIGHT & DAY® AQUA ASTIGMATISM; Multifocal - AIR OPTIX® NIGHT & DAY® AQUA MULTIFOCAL; and Multifocal Toric - AIR OPTIX® NIGHT & DAY® AQUA MULTIFOCAL TORIC and is indicated for the following:
AIR OPTIXC® NIGHT & DAY® AQUA (lotrafilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic
persons with non-diseased eyes who have 1.50 diopters or less of astigmatism.
AIR OPTIX® NIGHT & DAY® AQUA for ASTIGMATISM (lotrafilcon A) soft contact lenses
are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic
or aphakic persons with non-diseased eyes who have 6.00 diopters (D) or less of astigmatism.
AIR OPTIX® NIGHT & DAY® AQUA MULTIFOCAL (lotrafilcon A) soft contact lenses are
indicated for the optical correction of refractive ametropia (myopia and hyperopia) and/or
presbyopia in phakic or aphakic persons with non-diseased eyes who may require a reading
addition of +4.00 diopters (D) or less and who have 1.50 diopters or less of astigmatism.
AIR OPTIX® NIGHT & DAY® AQUA MULTIFOCAL TORIC (lotrafilcon A) soft contact
lenses are indicated for the optical correction of refractive ametropia (myopia, hyperopia,
astigmatism and presbyopia) in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and have 6.00 diopters (D) or less of astigmatism.
The lenses may be prescribed for daily wear or extended wear for up to 30 nights continuous wear with removal for disposal, or cleaning and disinfection (chemical not heat) prior to reinsertion, as recommended by the eye care professional.
Lotrafilcon A contact lenses are also indicated for therapeutic use. Use as a bandage to protect the corneal and to relieve corneal pain in the treatment of acute or chronic ocular pathologies,
such as bullous keratopathy, corneal erosions, entropion, corneal edema, and corneal dystrophies
as well as post-surgical conditions resulting from cataract extraction and corneal surgery.
Lotrafilcon A soft contact lenses for therapeutic use can also provide optical correction during
healing if required.
P010021/S021
11/10/11
Real-Time
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and CalibratorOrtho-Clinical Diagnostics, Inc.
Rochester, NY
14646
Approval for change in on-instrument storage of patient samples from 2 hours to 3 hours.
P010031/S178
11/9/11
180-Day
Protecta™ XT CRT-D, and Protecta™ CRT-D
Implantable Cardioverter Defibrillators with Cardiac Resynchronization,
Model SW009 Application Software vl.0 Systems
Medtronic, Inc.
Mounds View, MN
55112
Approval for the Protecta™ XT CRT-D, D314TRM and Protecta™ CRT-D
D334TRM Implantable Cardioverter Defibrillators with Cardiac Rcsynchronization, Protecta™
XT DR D314DRM and Protecta™ DR D334DRM Implantable Cardioverter Defibrillators,
Model SW009 Application Software vl.0, Carelink Monitor Model 2490C upgrade. CardioSight
Reader Model 2020A upgrade and Model 2491 DDMA upgrade.
P010031/S259
11/11/11
135-Day
Concerto II, Consulta, Maximo II, Protecta and Protecta XTMedtronic, Inc.
Mounds View, MN
55112
Approval for addition of a cleaning process at the supplier.
P010031/S277
11/17/11
Real-Time
Consulta CRT-D Maximo II CRT-D and Various Families of Concerto, InSync and ProtectaMedtronic, Inc.
Mounds View, MN
55112
Approval for an update to the operating system software for the CareLink Programmer associated with Medtronic pacemaker, implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) devices approved under the referenced PMA.
P010032/S039
11/2/11
135-Day
Genesis Line Neurostimulation IPG SystemsSt. Jude Medical
Plano, TX
75024
Approval to add an electronic switch supplier for the device.
P010054/S016
11/17/11
135-Day
Elecsys Anti-HBs ImmunoassayRoche Diagnostics
Indianapolis, IN
46250
Approval for changes to the manufacturing procedure for the bead coating process of the intermediate storage form of Elecys coated microparticles.
P020001/S009
11/18/11
Real-Time
STAN® S31 Fetal Heart MonitorNeoventa Medical AB
Moeindal, Sweden
SE-431 35
Approval for the addition of an accessory, the STAN Viewer Live, which allows remote viewing of an ongoing STAN S31 recording.
P020004/S062
11/10/11
180-Day
GORE® EXCLUDER® AAA EndoprosthesisW. L. Gore & Associated, Inc.
Flagstaff, AZ
86003
Approval for a manufacturing site located in Phoenix, Arizona.
P020004/S064
11/17/11
Real-Time
GORE® EXCLUDER® AAA EndoprosthesisW. L. Gore & Associated, Inc.
Flagstaff, AZ
86003
Approval for the addition of the 23 and 27 mm Contralateral Leg Component and several minor labeling changes.
P020025/S031
11/17/11
Real-Time
Maestro 3000 Cardiac Ablation SystemBoston Scientific Corporation
San Jose, CA
95134
Approval for the internal glue flap and the carton end closure changes to the packaging design.
P020027/S015
11/23/11
180-Day
Dimension Vista® 500 SystemSiemens Healthcare Diagnostics, Inc.
Newark, DE
19714
Approval for the Dimension Vista® FPSA Flex® reagent cartridge for use on the Dimension Vista® 500 System.
P020050/S006
11/23/11
180-Day
WaveLight® EX500 Laser SystemAlcon Laboratories, Inc.
Fort Worth, TX
76134
Approval for increased pulse frequency from 400 to 500 Hz, a new laser head, a
new housing with greater integration of accessories, modified laser pulse temporal parameters,
new eyetracker, new scanner, remodeled user interface, addition of networking capability, and
modified software. The device, as modified, will be marketed under the trade name WaveLight®
EX500 Laser System and is indicated for laser assisted in situ keratomileusis (LASIK) for:
1) the reduction or elimination of myopia of up to
-12.0 diopters (D) of sphere and up to
- 6.0 D of astigmatism at the spectacle plane in patients who are 18 years of age or older
with documentation of a stable manifest refraction defined as ≤ 0.50 D of preoperative
spherical equivalent shift over one year prior to surgery;
2) the reduction or elimination of hyperopic refractive errors up to +6.0 D of sphere with
and without astigmatic refractive errors up to 5.0 D at the spectacle plane, with a maximum manifest refraction spherical equivalent (MRSE) of +6.0 D in patients who
are 18 years of age or older with documentation of stable manifest refraction defined as
≤ 0.50 D of preoperative spherical equivalent shift over one year prior to surgery,
exclusive of changes due to unmasking latent hyperopia;
3) the reduction or elimination of naturally occurring mixed astigmatism of up to 6.00 D at
the spectacle plane in patients who are 21 years of age or older with documentation of a
stable manifest refraction defined as ≤ 0.50 D preoperative spherical equivalent shift over one year prior to surgery; and 4) the wavefront-guided (WFG) reduction or elimination of up to -7.00 D of spherical
equivalent myopia or myopia with astigmatism, with up to -7.00 D of spherical
component and up to 3.00 D of astigmatic component at the spectacle plane in patients who are 18 years of age or older with documentation of a stable manifest refraction defined as ≤ 0.50 D of preoperative spherical shift over one year prior to surgery.
P030008/S006
11/23/11
180-Day
WaveLight® EX500 Laser SystemAlcon Laboratories, Inc.
Fort Worth, TX
76134
Approval for increased pulse frequency from 400 to 500 Hz, a new laser head, a
new housing with greater integration of accessories, modified laser pulse temporal parameters,
new eyetracker, new scanner, remodeled user interface, addition of networking capability, and
modified software. The device, as modified, will be marketed under the trade name WaveLight®
EX500 Laser System and is indicated for laser assisted in situ keratomileusis (LASIK) for:
1) the reduction or elimination of myopia of up to
-12.0 diopters (D) of sphere and up to
- 6.0 D of astigmatism at the spectacle plane in patients who are 18 years of age or older
with documentation of a stable manifest refraction defined as ≤ 0.50 D of preoperative
spherical equivalent shift over one year prior to surgery;
2) the reduction or elimination of hyperopic refractive errors up to +6.0 D of sphere with
and without astigmatic refractive errors up to 5.0 D at the spectacle plane, with a maximum manifest refraction spherical equivalent (MRSE) of +6.0 D in patients who
are 18 years of age or older with documentation of stable manifest refraction defined as
≤ 0.50 D of preoperative spherical equivalent shift over one year prior to surgery,
exclusive of changes due to unmasking latent hyperopia;
3) the reduction or elimination of naturally occurring mixed astigmatism of up to 6.00 D at
the spectacle plane in patients who are 21 years of age or older with documentation of a
stable manifest refraction defined as ≤ 0.50 D preoperative spherical equivalent shift over one year prior to surgery; and 4) the wavefront-guided (WFG) reduction or elimination of up to -7.00 D of spherical
equivalent myopia or myopia with astigmatism, with up to -7.00 D of spherical
component and up to 3.00 D of astigmatic component at the spectacle plane in patients who are 18 years of age or older with documentation of a stable manifest refraction defined as ≤ 0.50 D of preoperative spherical shift over one year prior to surgery.
P030024/S017
11/10/11
Real-Time
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and CalibratorOrtho-Clinical Diagnostics, Inc.
Rochester, NY
14646
Approval for the change in on-instrument storage of patient samples from 2 hours to 3 hours.
P030026/S024
11/10/11
Real-Time
VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and CalibratorOrtho-Clinical Diagnostics, Inc.
Rochester, NY
14646
Approval for the change in on-instrument storage of patient samples from 2 hours to 3 hours.
P030028/S001
11/9/11
180-Day
Verisyse™ Phakic Intraocular Lens (PIOL)Ophtec Ev
Boca Raton, FL
33487
Approval of the post-approval study protocol.
P030036/S032
11/18/11
135-Day
SelectSecure LeadsMedtronic, Inc.
Mounds View, MN
55112
Approval for updates to the sterile packaging assembly process for new and existing sealer equipment.
P030054/S173
11/29/11
180-Day
Promote Q CRT-D,
Promote Quadra CRT-D, Unify Quadra CRT-D, Quartet LV Lead and Model 3330 version 12.1.1 Programmer Software
St. Jude Medical
Sunnyvale, CA
94086
Approval for Promote Q Model CD3221-36 CRT-D, Promote Quadra Models CD 3245-40/40Q CRT-D, Unify Quadra CRT-D Models CD3249-40/40Q CRT-D, Quartet Model 1458Q LV Lead, and Model 3330 version 12.1.1 Programmer Software.
P030054/S202
11/1/11
Real-Time
Fortify and Current Families of CRT-DsSt. Jude Medical
Sylmar, CA
91392
Approval for the introduction of the IS4/DF4 Port plug accessory model AC-IS4PP for use with all SJM DF4 or IS4 header ports.
P040027/S024
11/10/11
180-Day
Gore VIATORR TIPS EndoprosthesisW. L. Gore & Associates, Inc.
Flagstaff, AZ
86003
Approval for a manufacturing site located in Phoenix, Arizona.
P040048/S015
11/4/11
180-Day
Trilogy AB Acetabular SystemZimmer, Inc.
Warsaw, IN
46581
Approval of the Post-approval study protocol.
P050023/S047
11/17/11
180-Day
Lumax 500/540Biotronik, Inc.
Lake Oswego, OR
97035
Approval for the addition of the Thoracic Impedance (TI) measurement feature to the currently approved Lumax 500/540 Implantable Cardioverter Defibrillators and Cardiac Resynchronization Defibrillator devices.
P050049/S008
11/14/11
135-Day
Abbott AxSYM HBsAg
 
Abbott Laboratories
Abbott Park, IL
60064
Approval for a change to a supplier for an incoming raw material, nonfat dry milk (NFDM) that is a component of the AxSYM HBsAg Conjugate Diluent in the AxSYM HBsAg Reagent Pack in the AxSYM HBsAg assay.
P060011/S002
11/22/11
Real-Time
C-flex™ Aspheric Intraocular LensRayner Intraocular Lenses Limited
Laguna Beach, CA
92651
Approval for the addition of an aspheric optical surface to the anterior surface of the parent C-flex™ Aspheric Intraocular Lens Model 570C, as well as the addition of a Modulation Transfer Function (MTF) figure to the Physician’s Labeling comparing both models (i.e., 970C and 570C).
P060039/S021
11/22/11
180-Day
Medtronic Attain Starfix LeadMedtronic, Inc.
Mounds View, MN
55112
Approval for a change in the requirement for the copper content in the blue polyurethane tubing utilized by the Medtronic Attain StarFix™ lead from 200 ppm to 300 ppm.
P060039/S026
11/18/11
135-Day
Attain StarFix LeadsMedtronic, Inc.
Mounds View, MN
55112
Approval for updates to the sterile packaging assembly process for new and existing sealer equipment.
P070006/S007
11/23/11
Real-Time
T-SPOT.TB TestOxford Immunotec, Ltd.
Oxfordshire, England
OX144RY
Approval for the addition of a new test kit format with increased reagent volumes and 50 antibody coated 96-well microtitre plates to increase the kit capacity to a total of 1200 tests.
P070014/S027
11/17/11
Real-Time
LifeStent Solo Vascular Stent SystemBard Peripheral Vascular, Inc.
Tempe, AZ
85281
Approval for a smaller packaging configuration and minor labeling changes to accommodate the changes to the packaging.
P070022/S024
11/23/11
Real-Time
Adiana Permanent Contraception SystemHologic, Inc.
Marlborough, MA
01752
Approval for a change to the Adiana catheter to increase the flexibility for use with hysteroscopes with articulating tips.
P080006/S029
11/18/11
135-Day
Attain Ability LeadsMedtronic, Inc.
Mounds View, MN
55112
Approval for updates to the sterile packaging assembly process for new and existing sealer equipment.
P080007/S007
11/16/11
Real-Time
LifeStar Vascular Stent SystemBard Peripheral Vascular, Inc.
Tempe, AZ
85281
Approval for removal of the PerforMaXX grip on the delivery system, the addition of a smaller packaging configuration, and minor labeling changes. The device, as
modified, will be marketed under the trade name LifeStar Vascular Stent System and is indicated
for the treatment of iliac occlusive disease in patients with symptomatic vascular disease of the common and/or external iliac arteries up to
126 mm in length with a reference vessel diameter of
5 to 9 mm.
P080025/S004
11/9/11
135-Day
InterStim® II INSMedtronic Neuromodulation
Minneapolis, MN
55432
Approval for a modification to a cleaning process for hybrid components.
P080026/S002
11/30/11
135-Day
Abbott RealTime HBV AssayAbbott Molecular, Inc.
Des Plaines, IL
60018
Approval for a raw material change for two of the microvials used to manufacture the reagent components in the Abbott RealTime HBV Amplification kit within the Abbott RealTime HBV Assay.
P090002/S001
11/4/11
180-Day
Pinnacle CoMplete Acetabular System
 
DePuy Orthopaedics, Inc.
Warsaw, IN
46581
Approval of the post-approval study protocol.
P090007/S004
11/16/11
135-Day
Elecsys Anti-HCV Immunoassay on cobas e 411Roche Professional Diagnostics
Indianapolis, IN
46250
Approval for the in-process test method for determination of particle concentration of Elecsys coated microparticle (beads).
P090007/S005
11/17/11
135-Day
Elecsys Anti-HCV Immunoassay on cobas e 411Roche Diagnostics
Indianapolis, IN
46250
Approval for changes to the manufacturing procedure for the bead coating process of the intermediate storage form of Elecys coated microparticles.
P090008/S004
11/16/11
135-Day
Elecsys Anti-HCV Immunoassay on cobas e 601Roche Professional Diagnostics
Indianapolis, IN
46250
Approval for the in-process test method for determination of particle concentration of Elecsys coated microparticle (beads).
P090008/S005
11/17/11
135-Day
Elecsys Anti-HCV Immunoassay on cobas e 601Roche Diagnostics
Indianapolis, IN
46250
Approval for changes to the manufacturing procedure for the bead coating process of the intermediate storage form of Elecys coated microparticles.
P090009/S004
11/16/11
135-Day
Elecsys Anti-HCV Immunoassay on MODULAR ANALYTICS E170Roche Professional Diagnostics
Indianapolis, IN
46250
Approval for the in-process test method for determination of particle concentration of Elecsys coated microparticle (beads).
P090009/S005
11/17/11
135-Day
Elecsys Anti-HCV Immunoassay on MODULAR ANALYTICS E170Roche Diagnostics
Indianapolis, IN
46250
Approval for changes to the manufacturing procedure for the bead coating process of the intermediate storage form of Elecys coated microparticles.
P090013/S028
11/18/11
135-Day
CapSure FixMedtronic, Inc.
Mounds View, MN
55112
Approval for updates to the sterile packaging assembly process for new and existing sealer equipment.
P090013/S040
11/17/11
Real-Time
Revo MRIMedtronic, Inc.
Mounds View, MN
55112
Approval for an update to the operating system software for the CareLink Programmer associated with Medtronic pacemaker, implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) devices approved under the referenced PMA.
P090022/S009
11/16/11
135-Day
Softec HD, Softec I and Softec HD PS Intraocular LensesLenstec, Inc.
Saint Petersburg, FL
33716
Approval for the way in which a test reagent is incubated.
P100017/S001
11/30/11
135-Day
Abbott RealTime HCV AssayAbbott Molecular, Inc.
Des Plaines, IL
60018
Approval for a raw material change for two of the microvials used to manufacture the reagent components in the Abbott RealTime HCV Amplification kit within the Abbott RealTime HCV Assay.
P100031/S002
11/16/11
135-Day
Elecsys Anti-HBc Immunoassay on MODULAR ANALYTICS E170Roche Professional Diagnostics
Indianapolis, IN
46250
Approval for the in-process test method for determination of particle concentration of Elecsys coated microparticle (beads).
P100031/S004
11/17/11
135-Day
Elecsys Anti-HBc Immunoassay on MODULAR ANALYTICS E170Roche Diagnostics
Indianapolis, IN
46250
Approval for changes to the manufacturing procedure for the bead coating process of the intermediate storage form of Elecys coated microparticles.
P100032/S002
11/16/11
135-Day
Elecsys Anti-HBc Immunoassay on Elecsys 2010Roche Professional Diagnostics
Indianapolis, IN
46250
Approval for the in-process test method for determination of particle concentration of Elecsys coated microparticle (beads).
P100032/S004
11/17/11
135-Day
Elecsys Anti-HBc Immunoassay on Elecsys 2010Roche Diagnostics
Indianapolis, IN
46250
Approval for changes to the manufacturing procedure for the bead coating process of the intermediate storage form of Elecys coated microparticles.

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

APPLICATION NUMBER / DATE of APPROVALDEVICE TRADE NAMECOMPANY NAME CITY, STATE, & ZIPDEVICE DESCRIPTION / INDICATIONS
P810031/S041
11/3/11
Sodium Hyaluronate Ophthalmic Viscolastic Devices (OVD), Healon, Healon GV and Healon5 Ophthalmic Viscosurgical DevicesAbbott Medical Optics, Inc.
Santa Ana, CA
92705
Change in the Anti- Blocking additive in the Blister trays.
P820033/S008
11/2/11
Plasmaflo OP-05W(A)Asahi Kasei Kuraray Medical Company, Ltd.
Tokyo, Japan
101-8101
Moving the Plasmaflo manufacturing equipment to a new facility located within the current manufacturing site.
P840001/S197
11/10/10
Restore Family of Implantable NeurostimulatorsMedtronic, Inc.
Minneapolis, MN
55432
Update data entry during the wafer test process from a manual to an automated process.
P850007/S032
11/2/11
Physio-Stim, Spinal-Stim and Cervical-StimOrthofix, Inc.
Lewisville, TX
75056
Addition of an alternate battery pack supplier.
P850079/S051
11/29/11
Frequency 55, Frequency 58 UV. Frequency XCEL, Expression Colors, Expression Accents, Hydrasoft (methafilcon A and methafilcon B) Soft (Hydrophilic) Contact LensCooperVision, Inc.
Pleasanton, CA
94588
Change in the stability of shelf life protocol.
P860004/S160
11/10/11
SynchroMed Family of Infusion SystemsMedtronic, Inc.
Minneapolis, MN
55432
Update data entry during the wafer test process from a manual to an automated process.
P890023/S018
11/29/11
Biomedics 55 (ocufilcon D) Soft (Hydrophilic) Contact LensesCooperVision, Inc.
Pleasanton, CA
94588
Change in the stability shelf life protocol.
P900060/S047
11/29/11
Carbomedics Prosthetic Heart Valve (CPHV)Sorin Group USA, Inc.
Arvada, CO
80004
Alternate carbon coating process for CPHV sewing cuff manufacturing.
P910023/S277
11/23/11
Cadence/Current/ Promote Family of ICDsSt. Jude Medical
Sylmar, CA
91342
Addition of a device level test within the current suite of automated manufacturing tests.
P910023/S278
11/23/11
Cadence Family of ICDsSt. Jude Medical
Sylmar, CA
91342
Alternate automated inspection method for verification of connector seal integrity.
P910073/S099
11/18/11
RELIANCE 4-SITE IS-4 LeadsBoston Scientific Corporation
St. Paul, MN
55112
Change to the setup position in a seal test.
P930016/S036
11/17/11
STAR Excimer Laser and WaveScan WaveFront SystemAMO Manufacturing USA, LLC
Milpitas, CA
95035
Addition of a new capacitor and a replacement microscope tube.
P930029/S034
11/14/11
RF Contactr, RF Conductr, RF Marinr, RF Marinr 5Fr and RF Enhancer II Families of Ablation CathetersMedtronic, Inc.
Mounds View, MN
55112
 
Addition of an alternate supplier for various components.
P930038/S069
11/15/11
Angio-Seal Evolution Vascular Closure DeviceSt. Jude Medical, Inc.
St. Paul, MN
55117
Alternate method for ensuring stent deployment specification requirements.
P950029/S064
11/23/11
Reply SR/DR and Esprit SR/DR IPGsSorin CRM USA, Inc.
Plymouth, MN
55441
Implementation of alternate manufacturing equipment.
P950032/S065
11/22/11
ApligrafOrganogenesis, Inc.
Canton, MA
02021
Implementation of an alternate vendor.
P960009/S128
11/3/11
Model 37085 ExtensionMedtronic Neuromodulation
Minneapolis, MN
55432
Addition of a quality test to the manufacturing process.
P960009/S129
11/3/11
Soletra ImplantableMedtronic Neuromodulation
Minneapolis, MN
55432
Change to the cleaning process.
P960009/S130
11/10/11
Activa Family of Implantable NeurostimulatorsMedtronic, Inc.
Minneapolis, MN
55432
Reduction in sample size for incoming visual inspection of medical adhesive tubes.
P960009/S131
11/10/11
Activa Family of Implantable NeurostimulatorsMedtronic, Inc.
Minneapolis, MN
55432
Update data entry during the wafer test process from a manual to an automated process.
P960043/S076
11/23/11
Perclose Proglide Suture Medicated Closure SystemAbbott Vascular, Inc.
Redwood City, CA
94063
Replacement of ancillary Overmolding Press equipment.
P970003/S139
11/9/11
VNS Therapy®
System
Cyberonics, Inc.
Houston, TX
77058
Change to the welding parameters for the VNS pulse generators.
P980003/S032
11/10/11
Chilli II Catheter SystemBoston Scientific Corporation
San Jose, CA
95134
Change in supplier for sterile connector cables.
P980016/S324
11/2/11
Maximo II, Protecta, Protecta XT, Secura, Virtuoso IIMedtronic, Inc.
Mounds View, MN
55112
Automate data entry during wafer testing.
P980016/S326
11/30/11
Maximo II, Protecta, Protecta XT, Secura and Virtuoso IIMedtronic, Inc.
Mounds View, MN
55112
Removal of rejection criteria and associated re-clean process for flux bleed-out on RF modules.
P980035/S246
11/2/11
Adapta, Advisa, EnRhythm, Relia, Sensia, VersaMedtronic, Inc.
Mounds View, MN
55112
Automate data entry during wafer testing.
P980035/S247
11/23/11
350 Series, EnRhythm and Sigma IPGsMedtronic, Inc.
Mounds View, MN
55112
Consolidation of manufacturing operations and related equipment changes at a supplier’s location.
P980035/S248
11/23/11
AdvisaMedtronic, Inc.
Mounds View, MN
55112
Updates to a final functional test application.
P980049/S066
11/30/11
Paradym VR & DR ICDsSorin CRM
Plymouth, MN
55441
Use of an alternate reflow oven with an updated reflow soldering profile and an alternate component carrier.
P990001/S098
11/23/11
Vitatron DA+ C-Series and Vitatron DA+ T-Series IPGsMedtronic, Inc.
Mounds View, MN
55112
Consolidation of manufacturing operations and related equipment changes at a supplier’s location.
P990038/S014
11/15/11
ETI-MAK-2 PLUS KitDiaSorin, Inc.
Stillwater, MN
55082
Second vendor of Chromogen/ Substrate bulk solution.
P990041/S013
11/15/11
ETI-AB-EBK PLUS KitDiaSorin, Inc.
Stillwater, MN
55082
Second vendor of Chromogen/ Substrate bulk solution.
P990042/S010
11/15/11
ETI-AB-AUK PLUS KitDiaSorin, Inc.
Stillwater, MN
55082
Second vendor of Chromogen/ Substrate bulk solution.
P990044/S011
11/15/11
ETI-CORE-IGMK Plus KitDiaSorin, Inc.
Stillwater, MN
55082
Second vendor of Chromogen/ Substrate bulk solution.
P990045/S011
11/15/11
ETI-AB-COREK PLUS KitDiaSorin, Inc.
Stillwater, MN
55082
Second vendor of Chromogen/ Substrate bulk solution.
P990046/S025
11/15/11
Open Pivot Heart ValveMedtronic, Inc.
Minneapolis, MN
55432
Additional supplier of device component subassemblies.
P010015/S141
11/2/11
Consulta CRT-P, Syncra CRT-PMedtronic, Inc.
Mounds View, MN
55112
Automate data entry during wafer testing.
P010015/S143
11/23/11
InSync III CRT-DMedtronic, Inc.
Mounds View, MN
55112
Consolidation of manufacturing operations and related equipment changes at a supplier’s location.
P010015/S144
11/23/11
Consulta CRT-P, Syncra CRT-PMedtronic, Inc.
Mounds View, MN
55112
Updates to a final functional test application.
P010031/S278
11/2/11
Concerto II, Consulta, Maximo II, Protecta, Protecta XTMedtronic, Inc.
Mounds View, MN
55112
Automate data entry during wafer testing.
P010031/S279
11/30/11
Concerto II, Consulta, Maximo II, Protecta, Protecta XTMedtronic, Inc.
Mounds View, MN
55112
Removal of rejection criteria and associated re-clean process for flux bleed-out on RF modules.
P010032/S043
11/3/11
 
Genesis Line Neurostimulation (IPG) SystemsSt. Jude Medical
Plano, TX
75024
Implement a new pouch sealer to seal all terminally sterilized pouches.
P010047/S014
11/10/11
ProGel™ Pleural Air Leak SealantNeomend, Inc.
Irvine, CA
92618
Modifications in an inspection process.
P030034/S006
11/2/11
Physio-Stim, Spinal-Stim and Cervical-StimOrthofix, Inc.
Lewisville, TX
75056
Addition of an alternate battery pack supplier.
P030054/S204
11/23/11
Epic HF/Atlas HF/ Unity/Fortify Family of CRT-DsSt. Jude Medical
Sylmar, CA
91342
Addition of a device level test within the current suite of automated manufacturing tests.
P030054/S205
11/23/11
Epic HF/Atlas+ HF Family of CRT-DsSt. Jude Medical
Sylmar, CA
91342
Alternate automated inspection method for verification of connector seal integrity.
P040002/S034
11/4/11
Endoluminal ProsthesisEndologix, Inc.
Irvine, CA
92618
Inclusion of an additional storage facility.
P040014/S018
11/10/11
Therapy Cardiac Ablation SystemSt. Jude Medical
Irvine, CA
92614
Addition of an additional vendor to assemble printed circuit boards.
P040037/S039
11/23/11
GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive SurfaceW.L. Gore & Associates, Inc.
Flagstaff, AZ
86001
Software update for a trimming system.
P040042/S023
11/10/11
Therapy Dual 8 Cardiac Ablation SystemSt. Jude Medical
Irvine, CA
92614
Addition of an additional vendor to assemble printed circuit boards.
P050006/S025
11/4/11
Gore Helex Septal OccluderW.L. Gore & Associates
Flagstaff, AZ
86001
Replacement of equipment for measuring fiber diameter.
P050016/S008
11/10/11
Cormet Hip Resurfacing SystemCorin U.S.A.
Tampa, FL
33612
Modification to the type of manufacturing process for the device.
P050045/S003
11/10/11
TOP2 FISH pharmDx™ KitDako Denmark A/S
Glostrup, Denmark
DK-2600
Add an alternate supplier of Texas Red labeled dCTP nucleotide and to replace an in-process QC procedure with a new QC test on FFPE breast cancer tissue.
P060002/S022
11/17/11
Bard FLAIR Endovascular Stent GraftC.R. Bard, Inc.
Tempe, AZ
85281
Addition of a new system to monitor environmental controls.
P060019/S019
11/10/11
Therapy Cool Path Ablation Catheter and IBI RF Ablation GeneratorSt. Jude Medical
Irvine, CA
92614
Addition of an additional vendor to assemble printed circuit boards.
P060027/S033
11/30/11
Paradym CRT-DsSorin CRM
Plymouth, MN
55441
Use of an alternate reflow oven with an updated reflow soldering profile and an alternate component carrier.
P070014/S029
11/17/11
LifeStent Vascular Stent SystemsC.R. Bard, Inc.
Tempe, AZ
85281
Addition of a new system to monitor environmental controls.
P070015/S083
11/15/11
XIENCE V, XIENCE nano, and PROMUS Everolimus-Eluting Coronary StentsAbbott Vascular, Inc.
Temecula, CA
92591
Reduction in the frequency of monitoring a manufacturing process temperature.
P080007/S009
11/17/11
E-LUMINEXX Vascular StentC.R. Bard, Inc.
Tempe, AZ
85281
Addition of a new system to monitor environmental controls.
P080011/S006
11/29/11
Biofinity (comfilcon A) Soft (Hydrophilic) Contact LensCooperVision, Inc.
Pleasanton, CA
94588
Change in the stability shelf life protocol.
P090013/S041
11/2/11
Revo MRIMedtronic, Inc.
Mounds View, MN
55112
Automate data entry during wafer testing.
P090013/S043
11/23/11
Revo MRI IPGMedtronic, Inc.
Mounds View, MN
55112
Consolidation of manufacturing operations and related equipment changes at a supplier’s location.

Summary of PMA Originals & Supplements Approved
Originals: 6
Supplements: 106

Summary of PMA Originals Under Review
Total Under Review: 81
Total Active: 33
Total On Hold: 48
Number Greater Than 180 Days: 3

Summary of PMA Supplements Under Review
Total Under Review: 599
Total Active: 473
Total On Hold: 126
Number Greater Than 180 Days: 10

Summary of All PMA Submissions Received
Originals: 1
Supplements: 88

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 106
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 177
FDA Time: 133.5 Days MFR Time: 43.5 Days