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U.S. Department of Health and Human Services

Medical Devices

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April 2012 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 APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P090015
4/18/12
BOND™ ORACLE™ HER2 IHC System Leica Biosystems
Newcastle Upon Tyne, United Kingdom
NE128EW
Approval for the BOND™ ORACLE™ HER2 IHC System. This device is indicated for: Bond™ Oracle™ HER2 IHC System is a semi-quantitative immunohisto-chemical (IHC) assay to determine HER2 (Human Epidermal Growth Factor Receptor 2) oncoprotein status in formalin-fixed, parrafin embedded breast cancer tissue processed for histological evaluation following automated staining on the BOND-MAX™ slide staining instrument. The Bond™ Oracle™ HER2 IHC System is indicated as an aid in the assessment of patients for whom Herceptin® (trastuzumab) treatment is being considered.
P110004
4/12/12
Presillion™ plus CoCr Coronary Stent on RX System Medinol Ltd.
Tel-Aviv, Israel
61581
Approval for the Presillion™
plus CoCr Coronary Stent on RX System. This device is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease associated with stenotic lesions in de novo native coronary arteries (length ≤ 30 mm) with a reference vessel diameter of 2.50 mm to 4.00mm.
P110029
4/12/12
ARCHITECT HBsAg Qualitative,
ARCHITECT HBsAg Qualitative Confirmatory,
ARCHITECT HBsAg Qualitative Confirmatory Manual Diluent,
ARCHITECT HBsAg Qualitative Calibrators,
ARCHITECT HBsAg Qualitative Controls
Abbott Laboratories
Abbott Park, IL
60064
Approval for the
ARCHITECT HBsAg Qualitative, ARCHITECT HBsAg Qualitative Confirmatory, ARCHITECT
HBsAg Qualitative Confirmatory Manual Diluent, ARCHITECT HBsAg Qualitative Calibrators, and ARCHITECT HBsAg Qualitative Controls. This device is indicated for:
ARCHITECT HBsAg Qualitative -
The ARCHITECT HBsAg Qualitative assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of hepatitis B surface antigen (HBsAg) in human adult and pediatric serum and plasma and neonate serum. The assay may also be used to screen for HBV infection in pregnant women to identify neonates who are at risk for acquiring hepatitis B during the perinatal period. Assay results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with the hepatitis B virus (HBV) (state of infection or associated disease not determined) in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis B infection. Not intended for use in screening blood, plasma, or tissue donors.
ARCHITECT HBsAg Qualitative Confirmatory - The ARCHITECT HBsAg Qualitative Confirmatory assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative confirmation of the presence of hepatitis B surface antigen (HBsAg) in human adult and pediatric serum and plasma and neonate serum by means of specific antibody neutralization. Assay results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with the hepatitis B virus (HBV) (state of infection or associated disease not determined) in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis B infection. Not intended for use in screening blood, plasma, or tissue donors.
ARCHITECT HBsAg Qualitative Confirmatory Manual Diluent - The ARCHITECT HBsAg Qualitative Confirmatory Manual Diluent is used for manually diluting specimens for testing on the ARCHITECT i System using the ARCHITECT HBsAg Qualitative Confirmatory reagent kit. The performance of the ARCHITECT HBsAg Qualitative Confirmatory Manual Diluent has not been established with any other HBsAg assays.
ARCHITECT HBsAg Qualitative Calibrators - The ARCHITECT HBsAg Qualitative Calibrators are for the calibration of the ARCHITECT i System when used for qualitative detection of the presence of hepatitis B surface antigen (HBsAg) using the ARCHITECT HBsAg Qualitative and HBsAg Qualitative Confirmatory reagent kits. The performance of the ARCHITECT HBsAg Qualitative Calibrators has not been established with any other HBsAg assays.
ARCHITECT HBsAg Qualitative Controls - The ARCHITECT HBsAg Qualitative Controls are used for monitoring the performance of the ARCHITECT i System (reagents, calibrators, and instrument) when used for the qualitative detection of hepatitis B surface antigen (HBsAg) using the ARCHITECT HBsAg Qualitative and ARCHITECT HBsAg Qualitative Confirmatory reagent kits. The performance of the ARCHITECT HBsAg Qualitative Controls has not been established with any other HBsAg assays.
P110035
4/13/12
Epic™ Vascular Self-Expanding Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Approval for the Epic™ Vascular Self-Expanding Stent System. This device is indicated for the improvement of luminal diameter in patients with de novo or restenotic symptomatic atherosclerotic lesions up to 120 mm in length in the common and/or external iliac arteries, with a reference vessel diameter between 5 and 11 mm.

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
N12159/S030
4/26/12
Real-Time
SURGICEL SNoW Absorbable Hemostat Ethicon, Inc.
Somerville, NJ
08876
Approval for labeling changes including updated graphics, instructions for use, and language translations. The device, as modified, will be marketed under the trade name SURGICEL SNoW Absorbable Hemostat and is indicated for:
SURGICEL Absorbable Hemostat (oxidized regenerated cellulose) is used adjunctively in surgical procedures to assist in the control of capillary, venous, and small arterial hemorrhage when ligation or other conventional methods of control arc impractical or ineffective. SURGICEL ORIGINAL, SURGICEL FIBRILLAR, SURGICEL NUKNIT and SURGICEL SNoW Hemostats can be cut to size for use in endoscopic procedures.
SURGICEL® Absorbable Hemostat (oxidized regenerated cellulose) is indicated for adjunctive use to assist in the control of bleeding in exodontia and oral surgery. It may also be used to help achieve hemostasis after single or multiple tooth extractions, alveoloplasty, gingival hemorrhage, impactions, biopsies, and other procedures in the oral cavity.
P820003/S116
4/25/12
Real-Time
Various Families of Pasys, Spectrax, Symbios and Synergyst Medtronic, Inc.
Mounds View, MN
55112
Approval for software updates and minor software enhancements to
Medtronic Model 9986 Desktop/ Baseline Operating System Software (BOSS) Version 2.6 for the Medtronic Model 2090 CareLink Programmer.
P830061/S072
4/6/12
135-Day
Capsure Sense, CapSure SPNovus, Vitatron Crystalline, Vitatron Excellence+, Vitatron Excellence PS+ Medtronic, Inc.
Mounds View, MN
55112
Approval for changes to the incoming material specifications for active pharmaceutical ingredients used in the manufacture of steroid-eluding pacemaker leads.
P840001/S210
4/20/12
Special
RestorePrime, Prime Advanced, Restore, RestoreUltra,
RestoreAdvanced, Itrel 3, Synergy, and Synergy Versitrel Implantable
Neurostimulators (INS)
Medtronic Neuromodulation
Minneapolis, MN
55432
Approval for labeling changes to the manuals for the Model 37751 Recharge
Charger System, the Information for Prescribers Manual - Medtronic DBS Therapy, and the
Information for Prescribers Manual- Medtronic Pain Therapy Using Neurostimulation for Chronic Pain. These changes include the addition of precautions related to recharger use, modification of the device, and the effect of electromagnetic interference (EMI) on telemetry
communication.
P850048/S027
4/13/12
Special
Access Hybritech PSA Reagents on the Access Immunoassay Systems Beckman Coulter, Inc.
Chaska, MN
55318
Approval for new information to be added to the Instructions for Use, The Operator’s Guide and the Reference Manual, including the following: 1) Add instructions to the weekly maintenance sections of these documents for the inspection of the liquid waste bottles; 2) Clarify pack mixing instructions; 3) Add troubleshooting steps; 4) Change “cautions” into “warnings”; and
5) Change “notes” into “warnings”.
P850051/S079
4/25/12
Real-Time
Vitatron Legacy, Prevail, Premier and Various Families of Activitrax, Legend and Minix Medtronic, Inc.
Mounds View, MN
55112
Approval for software updates and minor software enhancements to
Medtronic Model 9986 Desktop/ Baseline Operating System Software (BOSS) Version 2.6 for the Medtronic Model 2090 CareLink Programmer.
P850089/S084
4/6/12
135-Day
CapSure SP, CapSure SP Novus, CapSure Z Novus, Vitatron Impulse II,
Vitatron Excellence S+, Vitatron Impulse
Medtronic, Inc.
Mounds View, MN
55112
Approval for changes to the incoming material specifications for active pharmaceutical ingredients used in the manufacture of steroid-eluding pacemaker leads.
P860003/S064
4/4/12
Special
Therakos™ CELLEX™ THERAKOS, Inc.
Raritan, NJ
08869
Approval for labeling changes to ensure the appropriate dosing of heparin for Low Body Weight patients.
P860004/S163
4/27/12
180-Day
Medtronic Side Access Port Kit, Medtronic IsoMed Refill Kit and Medtronic Refill Kit Medtronic Neuromodulation
Minneapolis, MN
55432
Approval for a manufacturing site located at Surgical Technologies, Inc. in Saint Paul, Minnesota.
P870056/S047
4/4/12
Special
Carpentier-Edwards Valved Conduit Edwards Lifesciences LLC
Irvine, CA
92614
Approval for adding text to the Warnings and Complications sections of the Edwards model 4300 Valved Conduit IFU in order to strengthen these statements.
P880006/S076
4/13/12
135-Day
Regency, Sensolog, Dialog St. Jude Medical, Inc.
Sylmar, CA
91342
Approval for changes to sterilization loading configurations.
P880081/S037
4/23/12
135-Day
CLARIFLEX IOL and Tecnis CL Silicone IOL Abbott Medical Optics, Inc.
Santa Ana, CA
92705
Approval for a change in the test method used to determine bacterial endotoxin levels of intraocular lenses.
P880086/S212
4/13/12
135-Day
AddVent, Affinity, Identity, Verity, Integrity, Victory, Zephyr, Accent,
Trilogy, Synchrony, Paragon, Phoenix, Entity
St. Jude Medical, Inc.
Sylmar, CA
91342
Approval for changes to sterilization loading configurations.
P880086/S216
4/13/12
Real-Time
Identity, Verity, Victory, Zephr, Sustain and Accent Family of devices St. Jude Medical
Sylmar, CA
91342
Approval for implementing Palladium-Iridium (Pd-Ir) alloy wire as an alternate to the existing Platinum-Iridium (Pt-Ir) alloy feedthru wire in St. Jude Medical high and low voltage pulse generators.
P890003/S237
4/6/12
135-Day
CapSure VDD-2, CapSure Brilliant S+ Medtronic, Inc.
Mounds View, MN
55112
Approval for changes to the incoming material specifications for active pharmaceutical ingredients used in the manufacture of steroid-eluding pacemaker leads.
P890003/S249
4/25/12
Real-Time
Prodigy, Minuet, Synergyst II, Preva, Thera, Vitatron Legacy, Reveal and various Families of Elite Medtronic, Inc.
Mounds View, MN
55112
Approval for software updates and minor software enhancements to
Medtronic Model 9986 Desktop/ Baseline Operating System Software (BOSS) Version 2.6 for the Medtronic Model 2090 CareLink Programmer.
P890055/S039
4/30/12
Real-Time
MedStream Programmable Infusion System Codman & Shurtleff Incorporated
Raynham, MA
02767
Approval of Control Unit circuitry hardware modifications which included Potentiometer value change, Resistance value change and Capacitor tolerance narrowing.
P900061/S114
4/25/12
Real-Time
Gem, PCD and Various Families of Jewel Medtronic, Inc.
Mounds View, MN
55112
Approval for software updates and minor software enhancements to
Medtronic Model 9986 Desktop/ Baseline Operating System Software (BOSS) Version 2.6 for the Medtronic Model 2090 CareLink Programmer.
P910023/S281
4/13/12
135-Day
Cadence, Cadet, Contour Contour II/MD, Angstrom II/MD, Profile 11/MD, Photon, Photon Micro, Current, Current+, Atlas II, Atlas II+,
Atlas, Atlas+, Epic II, Epic II+, Epic, Epic+, Convert, Convert+, Current
RF, Current Accel, Fortify
St. Jude Medical, Inc.
Sylmar, CA
91342
Approval for changes to sterilization loading configurations.
P910023/S287
4/6/12
Real-Time
Merline.net Software St. Jude Medical
Sylmar, CA
91342
Approval for the Merlin.net software version 6.0A.
P910023/S291
4/13/12
Real-Time
Atlas/+/II/II+, Epic/+II/II+, Current and Fortify Family of devices St. Jude Medical
Sylmar, CA
91342
Approval for implementing Palladium-Iridium (Pd-Ir) alloy wire as an alternate to the existing Platinum-Iridium (Pt-Ir) alloy feedthru wire in St. Jude Medical high and low voltage pulse generators.
P920015/S083
4/6/12
135-Day
Sprint Quattro Secure S, Spring Quattro Secure Sprint Medtronic, Inc.
Mounds View, MN
55112
Approval for changes to the incoming material specifications for active pharmaceutical ingredients used in the manufacture of steroid-eluding pacemaker leads.
P930014/S060
4/25/12
Real-Time
AcrySof® Intraocular Lens (IOL) and AcrySof® ReSTOR® IOL Alcon Research Ltd.
Fort Worth, TX
76134
Approval for modifications to the AcrySof® Intraocular Lens (IOL) case (#81) drainage features.
P930022/S014
4/25/12
Real-Time
Legend Plus Medtronic, Inc.
Mounds View, MN
55112
Approval for software updates and minor software enhancements to
Medtronic Model 9986 Desktop/ Baseline Operating System Software (BOSS) Version 2.6 for the Medtronic Model 2090 CareLink Programmer.
P930027/S014
4/5/12
135-Day
IMMULlTE®/
IMMULITE® 1000, IMMULITE® 2000, IMMULITE® 2500 PSA and IMMULlTE®/
IMMULITE® 1000, IMMULITE® 2000, IMMULITE® 2500 3 rd Generation PSA
Siemens Healthcare Diagnostics
Walpole, MA
02032
Approval for a change to remove the slip agent from the bottle used to package the IMMULITE substrate.
P930039/S063
4/6/12
135-Day
CapSure Fix Novus, CapSure Fix, SureFix, Vitatron Crystalline ActFix,
Vitatron Pirouet S+
Medtronic, Inc.
Mounds View, MN
55112
Approval for changes to the incoming material specifications for active pharmaceutical ingredients used in the manufacture of steroid-eluding pacemaker leads.
P950022/S080
4/13/12
135-Day
Riata, Riata ST, Riata ST Optim, Durata St. Jude Medical, Inc.
Sylmar, CA
91342
Approval for changes to sterilization loading configurations.
P950024/S037
4/6/12
135-Day
CapSure Epi Medtronic, Inc.
Mounds View, MN
55112
Approval for changes to the incoming material specifications for active pharmaceutical ingredients used in the manufacture of steroid-eluding pacemaker leads.
P950032/S068
4/3/12
Real-Time
Apligraf (Graftskin) Organogenesis, Inc.
Canton, MA
02134
Approval for the introduction of Human Epidermal Keratinocyte cell strain (HEP 170) into the manufacture of Apligraf.
P950034/S041
4/4/12
180-day
Seprafilm Adhesion Barrier Genzyme Biosurgery
Cambridge, MA
02142
Approval for a manufacturing site located at Genzyme Northborough Operations Center (gNOC) in Northborough, Massachusetts.
P950039/S024
4/9/12
Real-Time
ThinPrep Processor 2000/3000 Hologic, Inc.
Marlborough, MA
01752
Approval for an extension of the shelf life for ThinPrep Pap Test Filters.
P960009/S142
4/20/12
Special
Soletra, Kinetra, Activa PC, Activa SC and Activa RC INS Medtronic Neuromodulation
Minneapolis, MN
55432
Approval for labeling changes to the manuals for the Model 37751 Recharge
Charger System, the Information for Prescribers Manual - Medtronic DBS Therapy, and the
Information for Prescribers Manual- Medtronic Pain Therapy Using Neurostimulation for Chronic Pain. These changes include the addition of precautions related to recharger use, modification of the device, and the effect of electromagnetic interference (EMI) on telemetry
communication.
P960013/S069
4/13/12
135-Day
Tendril, Tendril ST, Tendril STS, OptiSense St. Jude Medical, Inc.
Sylmar, CA
91342
Approval for changes to sterilization loading configurations.
P960013/S071
4/13/12
Real-Time
Tendril ST, Tendril STS and OptiSense St. Jude Medical
Sylmar, CA
91342
Approval for modification to the connector boot on the IsoFlex, Tendril ST, Tendril STS, and OptiSense lead models, Tendril ST Models 1882, 1888, Tendril STS Models 1988, 2088 and OptiSense Model 1999.
P960028/S035
4/23/12
135-Day
REZOOM Multifocal IOL Abbott Medical Optics, Inc.
Santa Ana, CA
92705
Approval for a change in the test method used to determine bacterial endotoxin levels of intraocular lenses.
P960030/S034
4/13/12
135-Day
Passive Plus, IsoFlex S, IsoFlex P, Isoflex Optim St. Jude Medical, Inc.
Sylmar, CA
91342
Approval for changes to sterilization loading configurations.
P960030/S035
4/13/12
Real-Time
IsoFlex Optim St. Jude Medical
Sylmar, CA
91342
Approval for a modification to the connector boot on the IsoFlex models, IsoFlex Optim Models 1944 and 1948.
P960042/S031
4/20/12
180-Day
GlideLight Laser Sheath Spectranetics Corporation
Colorado Springs, CO
80921
Approval for an increase in the maximum repetition rate from 40 Hz to 80 Hz of the Spectranetics Laser Sheath. The device, as modified, will be marketed under the trade name GlideLight Laser Sheath.
P960058/S091
4/27/12
180-Day
Auria Harmony HiResolution Bionic Ear System Advanced Bionics, LLC
Sylmar, CA
91342
Approval of design changes implemented in the approved HiRes 90K cochlear
implant device. The device, as modified, will be marketed under the trade name "HiRes+90K™
Advantage", hereafter referred to as "Advantage." This modified cochlear implant design will be
marketed under a new model number (CI-1500-XXX) and the brand name for the HiRes 90K
cochlear implant, "Auria Harmony HiRcsolution Bionic Ear System" will be changed to
"HiResolution Bionic Ear System." The Advantage implant includes the following: a reinforced antenna coil and an integrated silicons pocket for the magnet. The implant digital integrated
circuit has also been revised to include the latest wafer assembly processes.
P960058/S094
4/2/12
180-Day
Harmony HiResolution Bionic Ear System
 
Advanced Bionics, LLC
Sylmar, CA
91342
Approval for a new accessory, called
T-Comm, for Advanced Bionics bodyworn
sound processors. This accessory allows the use of the currently-approved T-Mic to be used
with the body-worn sound processors. The T-Comm also incorporates a telecoil. A switch allows the user to select between
T-Mic, telecoil, or a 50/50 mix of the two inputs.
P970004/S124
4/10/12
180-Day
InterStim® Therapy System for Urinary Control Medtronic Neuromodulation
Minneapolis, MN
55432
Approval for updating the labeling to allow particular types of MRI scans to be performed while the devices are implanted and for associated changes in the product specification of Model 3023 InterStim Neurostimulator.
P970012/S091
4/25/12
Real-Time
Kappa 400 Medtronic, Inc.
Mounds View, MN
55112
Approval for software updates and minor software enhancements to
Medtronic Model 9986 Desktop/ Baseline Operating System Software (BOSS) Version 2.6 for the Medtronic Model 2090 CareLink Programmer.
P970013/S045
4/13/12
135-Day
Microny St. Jude Medical, Inc.
Sylmar, CA
91342
Approval for changes to sterilization loading configurations.
P970037/S007
4/27/12
135-Day
AutoDELFIA/ DELFIA Xpress hAFP Kit PerkinElmer, Inc.
Waltham, MA
02451
Approval for a change of the dispensing line used in the manufacturing of the calibrators for the AutoDELFIA and DELFIA Xpress hAFP kits and the
Buffer Solution for the DELFIA Xpress hAFP kit.
P970038/S016
4/13/12
Special
Access Hybritech Free PSA Reagents on the Access Immunoassay Systems Beckman Coulter, Inc.
Chaska, MN
55318
Approval for new information to be added to the Instructions for Use, the Operator’s Guide and the Reference Manual, including the following: 1) Add instructions to the weekly maintenance sections of these documents for the inspection of the liquid waste bottles; 2) Clarify pack mixing instructions; 3) Add troubleshooting steps; 4) Change “cautions” into “warnings”; and
5) Change “notes” into “warnings”.
P980016/S325
4/6/12
135-Day
CapSure Fix Medtronic, Inc.
Mounds View, MN
55112
Approval for changes to the incoming material specifications for active pharmaceutical ingredients used in the manufacture of steroid-eluding pacemaker leads.
P980016/S339
4/16/12
Real-Time
Secura/Maximo II/ Protecta/Protecta XT/Entrust/Entrust DR Medtronic, Inc.
Mounds View, MN
55112
Approval for an update to the life test specifications of high voltage capacitors.
P980016/S347
4/25/12
Real-Time
Entrust, Intrinsic, Marquis, Onyx, Secura and Various Families of Gem, Maximo, Protecta and Virtuoso Medtronic, Inc.
Mounds View, MN
55112
Approval for software updates and minor software enhancements to
Medtronic Model 9986 Desktop/ Baseline Operating System Software (BOSS) Version 2.6 for the Medtronic Model 2090 CareLink Programmer.
P980022/S102
4/30/12
180-Day
Paradigm REAL-TIME System, Guardian REAL-Time System, Paradigm REAL-Time Revel System and iPro Continuous Glucose Monitoring (CGM) System Medtronic, Inc.
Northridge, CA
91325
Approval for a manufacturing site located at IntriCon Corporation in Arden Hills, Minnesota.
P980022/S105
4/25/12
135-Day
Guardian REAL- TIME System Medtronic MiniMed, Inc.
Northridge, CA
91325
Approval for a manufacturing location change from China to Vietnam.
P980022/S112
4/27/12
Real-Time
Paradigm REAL-Time Revel System Medtronic, Inc.
Northridge, CA
91325
Approval for software modifications (Version 2.5A) and related labeling modifications for the Paradigm REAL-Time Revel Insulin Pump (Models MMT-532, MMT-723, MMT-523K, MMT723K). The Paradigm Revel Insulin Pump is a component of the Paradigm REAL-Time Revel System.
P980022/S113
4/18/12
Real-Time
Paradigm REAL-Time Continuous Glucose Monitoring System and Paradigm REAL-Time Revel Continuous Glucose Monitoring System Medtronic, Inc.
Northridge, CA
91325
Approval for an alternate supercapacitor, a component used on the Interface Boards of the Paradigm Real-time Pump (models MMT-522, -522K, -722, 722K) and Paradigm REAL-Time Revel Pump (models MMT-523, -523K,
-723, -723K) which are components of the devices.
P980022/S115
4/26/12
Real-Time
Paradigm REAL-Time, Guardian REAL-Time and iPro Continuous Glucose Monitoring Systems Medtronic, Inc.
Northridge, CA
91325
Approval for a change from a single cavity injection mold to a two cavity
injection mold for the manufacture of the connector housing and contact components of
the MiniLink Transmitter
(MMT-7703) and iPro Digital Recorder
(MMT-7709). The MiniLink Transmitter and iPro Digital Recorder are components of Paradigm REAL-Time, Guardian
REAL-Time and iPro Continuous Glucose Monitoring Systems.
P980035/S268
4/25/12
Real-Time
Adapta, Advisa, AT500, EnPulse, EnRhythm, Relia, Sensia, Sigma, Versa, Jewel AF, Gem III AT and Various Families of Kappa Medtronic, Inc.
Mounds View, MN
55112
Approval for software updates and minor software enhancements to
Medtronic Model 9986 Desktop/ Baseline Operating System Software (BOSS) Version 2.6 for the Medtronic Model 2090 CareLink Programmer.
P980040/S037
4/23/12
135-Day
SENSAR Soft Acrylic Posterior Chamber Intraocular Lenses (IOL), Tecnis Soft Acrylic IOL, CLARIFLEX IOL, Tecnis CL Silicone IOL and REZOOM Multifocal IOL Abbott Medical Optics, Inc.
Santa Ana, CA
92705
Approval for a change in the test method used to determine bacterial endotoxin levels of intraocular lenses.
P980041/S017
4/13/12
Special
Access AFP Reagents on the Access Immunoassay Systems Beckman Coulter, Inc.
Chaska, MN
55318
Approval for new information to be added to the Instructions for Use, the Operator’s Guide and the Reference Manual, including the following: 1) Add instructions to the weekly maintenance sections of these documents for the inspection of the liquid waste bottles; 2) Clarify pack mixing instructions; 3) Add troubleshooting steps; 4) Change “cautions” into “warnings”; and
5) Change “notes” into “warnings”.
P980049/S065
4/10/12
180-Day
Paradym RF ICD Sorin CRM USA, Inc.
Plymouth, MN
55441
Approval for the Paradym RF CRT-D and Paradym RF ICD.
P980050/S070
4/16/12
Real-Time
GEM III AT Medtronic, Inc.
Mounds View, MN
55112
Approval for an update to the life test specifications of high voltage capacitors.
P980050/S073
4/25/12
Real-Time
Diva IPG Family, Dema IPG Family, Various AFm C-series and T-series Devices Medtronic, Inc.
Mounds View, MN
55112
Approval for software updates and minor software enhancements to
Medtronic Model 9986 Desktop/ Baseline Operating System Software (BOSS) Version 2.6 for the Medtronic Model 2090 CareLink Programmer.
P990001/S104
4/25/12
Real-Time
Vitatron IPGs Medtronic, Inc.
Mounds View, MN
55112
Approval for software updates and minor software enhancements to
Medtronic Model 9986 Desktop/ Baseline Operating System Software (BOSS) Version 2.6 for the Medtronic Model 2090 CareLink Programmer.
P990034/S025
4/27/12
180-Day
Medtronic Side Access Port Kit, Medtronic IsoMed Refill Kit and Medtronic Refill Kit Medtronic Neuromodulation
Minneapolis, MN
55432
Approval for a manufacturing site located at Surgical Technologies, Inc. in Saint Paul, Minnesota.
P990046/S027
4/3/12
Special
Open Pivot® Aortic Valved Graft Medtronic, Inc.
Minneapolis, MN
55432
Approval for adding text to the Open Pivot® Aortic Valved Graft Instructions for Use (IFU) to strengthen the cauterization precaution statement.
P990080/S036
4/23/12
135-Day
Tecnis Soft Acrylic IOL Abbott Medical Optics, Inc.
Santa Ana, CA
92705
Approval for a change in the test method used to determine bacterial endotoxin levels of intraocular lenses.
P000025/S054
4/20/12
Real-Time
MED-EL COMBI40+ Cochlear Implant System MED-EL Corporation
Durham, NC
27713
App r oval fo r a c h ange t o th e p ackag in g co n fig u ra t io n o f the SONA T A TI 100
coc hl ear i mp l a nt a nd th e Im p l a nt T e m p l a t e, S in g l e Use, fo r th e SONA T A TI 100.
This c h ang e w ill e n ab l e th e SONATA S in g l e Use Te mpl a t e to b e s hipp e d t oge th e r w ith th e
SONA T A TI 100 coc hl ea r im p l a nt in s ide th e impl a nt box.
P000025/S057
4/30/12
180-Day
MED-EL COMBI40+ Cochlear Implant System MED-EL Corporation
Durham, NC
27713
Approval for the following:
1) +FLEX 28,
+FLEX 24 and FLEX 24 electrode variants for the SONATA TI 100 and Mil000 MED-EL CONCERT cochlear implants;
2) +Standard, +Medium and +Compressed electrode variants for the SONATA TI 100 cochlear implant; and 3) new variants of the single use surgical Insertion Electrode tool (Standard, Medium,
Compressed, FLEX 24 and
FLEX 28).
P000036/S008
4/18/12
180-Day
Dermagraft Human Fibroblast – Derived Dermal Substitute Advanced BioHealing, Inc.
La Jolla, CA
92037
Approval for manufacturing sites located at FlexMedical, in Tijuana, Baja California, Mexico and Advanced BioHealing Inc., in San Diego, California.
P000040/S021
4/23/12
180-Day
Genesys HTA System Boston Scientific Corporation
Marlborough, MA
01752
Approval of the post-approval study protocol.
P010001/S009
4/19/12
135-Day
Ceramic Transcend Hip Articulation System CeramTec GmbH
Ferndale, MI
48220
Approval for use of additional and replacement machines for grinding, polishing and dimensional inspection.
P010007/S008
4/5/12
135-Day
IMMULlTE®/
IMMULITE® 1000, IMMULITE® 2000, IMMULITE® 2500 AFP
Siemens Healthcare Diagnostics
Walpole, MA
02032
Approval for a change to remove the slip agent from the bottle used to package the IMMULITE substrate.
P010015/S142
4/6/12
135-Day
Attain OTW Medtronic, Inc.
Mounds View, MN
55112
Approval for changes to the incoming material specifications for active pharmaceutical ingredients used in the manufacture of steroid-eluding pacemaker leads.
P010015/S160
4/25/12
Real-Time
Consulta CRT-P, Syncra CRT-P, InSync and InSync III Medtronic, Inc.
Mounds View, MN
55112
Approval for software updates and minor software enhancements to
Medtronic Model 9986 Desktop/ Baseline Operating System Software (BOSS) Version 2.6 for the Medtronic Model 2090 CareLink Programmer.
P010031/S232
4/4/12
Panel-Track
Concerto CRT-D,
Consulta CRT-D,
Maximo II CRT-D,
Concerto II CRT-D,
Protccta CRT-D,
Protecta CRT-D,
Protecta XT
CRT-D, Protecta XT CRT-D, Consulta CRT-D and Maximo II CRT-D
Medtronic, Inc.
Mounds View, MN
55112
Approval for a
modification to the indications for use as follows.
For the Concerto CRT-D Model C154DWK, Consulta CRT-D Model D224TRK, Concerto II
CRT-D Model D274TRK, Protecta CRT-D Model D334TRG, Protecta CRT-D Model
D334TRM, Protecta XT CRT-D Model D314TRG, Protecta XT CRT-D Model D314TRM, and
Consulta CRT-D Model D204TRM Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) the indications for use are:
The CRT-D system is indicated for ventricular antitachycardia pacing and
ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias
and for providing cardiac resynchronization therapy in heart failure patients who remain symptomatic despite optimal medical therapy, and meet any of the following classifications:
1) New York Heart Association (NYHA) Functional Class III or IV and who have a left
ventricular ejection fraction ≤ 35% and a prolonged QRS duration.
2) Left bundle branch block (LBBB) with a QRS duration
≥ 130 ms, left ventricular ejection
fraction ≤ 30%, and NYHA Functional Class II.
The system is also indicated for use in patients with atrial tachyarrhythmias, or those patients who are at significant risk for developing atrial tachyarrhythmias.
Atrial rhythm management features such as Atrial Rate Stabilization (ARS), Atrial Preference Pacing (APP), and Post Mode Switch Overdrive (PMOP) are indicated for the
suppression of atrial tachyarrhythmias in implantable cardioverter defibrillator (ICD)-
indicated patients with atrial septal lead placement and an ICD indication.
For the Maximo II CRT-D Model D284TRK and Maximo IICRT-D Model D264TRM Cardiac
Resynchronization Therapy Defibrillators
(CRT-Ds) the indications for use are:
The Maximo II CRT-D system is indicated for ventricular antitachycardia pacing and
ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias
and for providing cardiac resynchronization therapy in heart failure patients who remain
symptomatic despite optimal medical therapy, and meet any of the following classifications:
1) New York Heart Association (NYHA) Functional Class III or IV and who have a left
ventricular ejection fraction ≤ 35% and a prolonged QRS duration.
• Left bundle branch block (LBBB) with a QRS duration
≥ 130 ms, left ventricular ejection
fraction ≤ 30%, and NYHA Functional Class II.
 
P010031/S292
4/16/12
Real-Time
Consulta/Maximo II/Protecta/Protecta XT Medtronic, Inc.
Mounds View, MN
55112
Approval for an update to the life test specifications of high voltage capacitors.
P010031/S299
4/25/12
Real-Time
Consulta CRT-D, Maximo II, Concerto, Concerto II, and Various Families of InSync and Protecta Medtronic, Inc.
Mounds View, MN
55112
Approval for software updates and minor software enhancements to
Medtronic Model 9986 Desktop/ Baseline Operating System Software (BOSS) Version 2.6 for the Medtronic Model 2090 CareLink Programmer.
P010032/S048
4/10/12
Real-Time
S-Series Lamitrode Leads St. Jude Medical
Plano, TX
75024
Approval for modifications to the electrode design on the S-Series Lamitrode Lead Models 3243, 3246, 3283, 3286, 3266 and 3268.
P010054/S017
4/23/12
180-Day
Elesys Anti-HBs Test System Roche Diagnostics
Indianapolis, IN
46250
Approval for the extension of the Elecsys Anti-HBs Test System onto the cobas e 602 immunoassay analyzer. The device, as modified, will be marketed under the trade name Elecsys Anti-HBs Test System and is indicated for: Elecsys Anti-HBs Immunoassay - Immunoassay for the in vitro quantitative determination of total antibodies to the hepatitis B surface antigen (HBsAg) in human serum and plasma (EDTA). The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys 2010, MODULAR ANALYTICS E170 (Elecsys Module), cobas e 411, cobas
e 601, and cobas
e 602 immunoassay analyzers. Assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection for individuals prior to or following HBV vaccination, or where vaccination status is unknown. Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection. A reactive assay result will allow a
differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is
unknown. The detection of anti-HBs is indicative of laboratory diagnosis of seroconversion from hepatitis B virus (HBV) infection.
P020014/S036
4/19/12
180-Day
Essure System for Permanent Birth Control Conceptus, Inc.
Mountain View, CA
94041
Approval for a manufacturing site located at Precision Wire Components, in Tualatin, Oregon.
P020018/S040
4/4/12
Panel-Track
Zenith® Fenestrated AAA Endovascular Graft Cook, Inc.
Bloomington, IN
47402
Approval for
the Zenith Feneslraled AAA Endovascular Graft (with the adjunctive Zenith Alignment Stent). The Zenith Fenestrated AAA Endovascular Graft is indicated for the endovascular treatment of
patients with abdominal aortic or aortolliac aneurysms having morphology suitable for
endovascular repair, including:
1) Adequate iliac/femoral access compatible with required introduction systems;
2) Nonaneurysmal infrarenal aortic segment (neck) proximal to the aneurysms with:
a) Length ≥ 4 mm and unsuitable for a non-fenestratcd graft;
b) Diameter ≤ 31 mm and ≥ 19 mm;
c) Angle < 45 degrees relative to long axis of aneurysm; and
d) Angle < 45 degrees relative to axis of suprarenal aorta. 3) Ipsilateral iliac artery fixation site > 30 mm in length and between 9-21 mm in diameter; and
4) Contralateral iliac artery distal fixation site > 30 mm in length and between 7-21 mm in diameter.
The Zenith Alignment Stent is indicated for use as an adjunct to the Zenith Fcnestraled AAA Endovascular Graft to secure positive alignment of fenestrations or scallops with the orifice of aortic branch vessels having diameters ranging from 3 to 8 mm.
P020018/S042
4/13/12
180-Day
Zenith Flex® AAA Endovascular Graft Cook Inc.
Bloomington, IN
47402
Approval for changes to the instructions for use (IFU) labeling. The labeling changes involved recommendations to users regarding maintaining hemostasis, use of fluoroscopy and trigger wire release, and an alternative suprarenal deployment sequence.
P020045/S042
4/12/12
Real-Time
Freezor® Cardiac CryoAblation Catheters, Freezor® Xtra and Freezor® MAX Surgical CryoAblation Devices and CCT.2 CryoConsole System Medtronic CryoCath, LP Quebec, Canada
H9R 5Z8
Approval for a modification to allow the use of the Arctic Front Advance™ balloon catheter (Models 2AF234 & 2AF284) with the CryoConsole Model #106A3 and is indicated for use in performing cardiac ablation procedures.
P020047/S042
4/3/12
Real-Time
MULTI-LNK 8 Coronary Stent System Abbott Vascular
Temecula, CA
92591
Approval for changes to the MULTI-LINK 8 Coronary Stent System Instructions for Use (IFU) to align/update the IFU verbiage with a recently approved coronary stent system.
P030004/S005
4/5/12
Special
Onyx® Liquid Embolic System ev3 Neurovascular
Irvine, CA
92618
Approval for changes to the instructions for use and patient brochure that strengthen the warnings about catheter entrapment.
P030017/S130
4/10/12
Real-Time
Precision® Spinal Cord Stimulation System Boston Scientific Neuromodulation
Valencia, CA
91355
Approval for a new outer carton for the Implantable Pulse Generator (IPG) Kits, Infinion 1x16 Lead Kits and 2x8 Splitter Kits.
P030035/S090
4/13/12
135-Day
Frontier, Frontier II, Anthem, Aescula St. Jude Medical, Inc.
Sylmar, CA
91342
Approval for changes to sterilization loading configurations.
P030035/S094
4/13/12
Real-Time
Frontier II and Anthem Family of devices St. Jude Medical
Sylmar, CA
91342
Approval for implementing Palladium-Iridium (Pd-Ir) alloy wire as an alternate to the existing Platinum-Iridium (Pt-Ir) alloy feedthru wire in St. Jude Medical high and low voltage pulse generators.
P030054/S208
4/13/12
135-Day
QuickSite, Quickflex, Quickflex Micro, Quartet, Epic HF, Epic+ HF, Epic II HF, Epic II+ HF, Atlas HF, Altas+ HF, Atlas II HF, Atlas II+ HF,
Promote, Promote+, Promote RF, Promote Accel, Unify, Unify Quadra
St. Jude Medical, Inc.
Sylmar, CA
91342
Approval for changes to sterilization loading configurations.
P030054/S218
4/13/12
Real-Time
Atlas/+HF/II HF /II+HF, Epic/+ HF/II HF/II+ HF, Promote and Unify Family of Devices St. Jude Medical
Sylmar, CA
91342
Approval for implementing Palladium-Iridium (Pd-Ir) alloy wire as an alternate to the existing Platinum-Iridium (Pt-Ir) alloy feedthru wire in St. Jude Medical high and low voltage pulse generators.
P040021/S021
4/13/12
Special
Bicor™ & Bicor™ Supra Valves, Epic™ & Epic™ Supra Valves St. Jude Medical
St. Paul, MN
55117
Approval for revising the instruction regarding “suture tails”.
P040024/S055
4/23/12
135-Day
Restylane Injectable Gel Medicis Pharmaceutical Corporation
Scottsdale, AZ
85256
Approval for the following changes:
1) change to label check criteria;
2) extension of compressed air distribution in Building 9 (phase 2); 3) sealing of vessels after Clean out of Place (COP) using Steriking pouch; 4) changed sampling procedure for bioburden and bacterial endotoxins tests; 5) new siliconization and Luer lock adaptor assembly processes 1mL glass syringe at BD; 6) tightening of analytical acceptance limits for HA content and gel content. Change Involves modification of acceptance criteria for incoming raw material, for a critical component;
7) tightening limits for Lidocaine in process control and changing from a calculated to a fixed amount of added water for injection (WFI); and
8) installation of new differential pressure sensors.
P040044/S043
4/5/12
Real-Time
MynxGrip™ Vascular Closure Device Access Closure
Mountain View, CA
94043
Approval for adding a 5F version to the MynxGrip™ product line. The device, as modified, will be marketed under the trade name MynxGrip™ Vascular Closure
Device and is indicated for use lo seal femoral arterial access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 5F, 6F or 7F procedural sheath.
P050012/S042
4/18/12
135-Day
Dexcom SEVEN® and SEVEN® PLUS Continuous Glucose Monitoring Systems Dexcom, Inc.
San Diego, CA
92121
Approval of an additional supplier manufacturing facility at Flextronics Technology (Shenzhen), at Gushu.
P050039/S007
4/27/12
135-Day
Novation Ceramic Articulation Hip System (AHS) Exactech, Inc.
Gainesville, FL
32653
Approval for use of an additional package sealer for the acetabular liner and femoral head sterile barrier packaging processes.
P050039/S009
4/26/12
Special
Exatech® Novation® Ceramic AHS® Articulation Hip System Exactech, Inc.
Gainesville, FL
32653
Approval for changes to the Novation® AHS Instructions for Use to reorganize information for clarity, remove information that is redundant, and ensure consistency.
P060005/S007
4/5/12
135-Day
IMMULlTE®/
IMMULITE® 1000, IMMULITE® 2000 Free PSA
Siemens Healthcare Diagnostics
Walpole, MA
02032
Approval for a change to remove the slip agent from the bottle used to package the IMMULITE substrate.
P060027/S032
4/10/12
180-Day
Paradym RF CRT-D Sorin CRM USA, Inc.
Plymouth, MN
55441
Approval for the Paradym RF CRT-D and Paradym RF ICD.
P070015/S086
4/5/12
135-Day
XIENCE V Everolimus Eluting Coronary Stent System Abbott Vascular
Temecula, CA
92591
Approval for a change in subassembly packaging.
P070015/S092
4/13/12
180-Day
XIENCE V Everolimus Eluting Coronary Stent System Abbott Vascular
Temecula, CA
92591
Approval of the post-approval study protocol.
P080004/S004
4/4/12
180-Day
Clear-optic Spheric and Aspheric Surface Intraocular Lenses (IOLs) Hoya Surgical Optics, Inc.
Chino Hills, CA
91709
Approval for Clear-Optic Spheric and Aspheric Surface Intraocular Lenses (lOLs), Models PC-60R, PC-60AD and FC-60AD.
P080006/S035
4/6/12
135-Day
Attain Ability Medtronic, Inc.
Mounds View, MN
55112
Approval for changes to the incoming material specifications for active pharmaceutical ingredients used in the manufacture of steroid-eluding pacemaker leads.
P080025/S016
4/10/12
180-Day
IntersStim® Therapy System for Bowel Control Medtronic Neuromodulation
Minneapolis, MN
55432
Approval for updating the labeling to allow particular types of MRI scans to be performed while the devices are implanted and for associated changes in the product specification of Model 3023 InterStim Neurostimulator.
P090002/S002
4/17/12
Real-Time
DePuy Pinnacle® CoMplete® Acetabular Hip System DePuy Orthopaedics, Inc.
Warsaw, IN
46581
Approval for the addition of the Trilock® BPS (Bone Preserving Hip Stem) to the list of compatible femoral stem components. The device, as modified, will be marketed under the trade name DePuy Pinnacle® CoMplete® Acetabular Hip System and is indicated as a single use device intended for uncemented fixation. The device is intended as a primary joint replacement prosthesis in total hip arthroplasty for skeletally mature patients suffering at least moderate pain in the hip joint from non-inflammatory degenerative joint disease (NIDJD) and its composite diagnoses of osteoarthritis (OA) or post-traumatic arthritis. The device’s inserts (Pinnacle® Ultamet®) are only intended for use with DePuy’s femoral and acetabular components having matching outer and inner diameters.
P090008/S006
4/25/12
180-Day
Elecsys Anti-HCV Immunoassay and PreciControl Anti- HCV Immunoassay Roche Diagnostics
Indianapolis, IN
46250
Approval for the extension of the Elecsys Anti-HCV Immunoassay and
PreciControl Anti-HCV Immunoassay onto the cobas e 602 immunoassay analyzer. The device, as modified, will be marketed under the trade name Elecsys Anti-HCV Immunoassay and is indicated for:
Elecsys Anti-HCV Immunoassay -
The Elecsys Anti-HCV Immunoassay is an in vitro diagnostic test for the qualitative
detection of total antibodies to hepatitis C virus (anti-HCV) in human serum or plasma (potassium EDTA, lithium heparin and sodium heparin). Assay results, in conjunction with other laboratory results and clinical information, may
be used to aid in the presumptive diagnosis of HCV infection in persons with signs and
symptoms of hepatitis and in persons at risk for hepatitis C infection. This test does not determine the state of infection or associated disease. The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e 601 and cobas e 602 immunoassay analyzers.
P090013/S042
4/6/12
135-Day
Capsure Fix Novus Medtronic, Inc.
Mounds View, MN
55112
Approval for changes to the incoming material specifications for active pharmaceutical ingredients used in the manufacture of steroid-eluding pacemaker leads.
P090013/S059
4/23/12
Real-Time
Capsurefix MRI Surescan 5086 MRI Medtronic, Inc.
Mounds View, MN
55112
Approval for a change to the package configuration for the Model 5086 MRI SureScan lead.
P090013/S061
4/25/12
Real-Time
Revo MRI Medtronic, Inc.
Mounds View, MN
55112
Approval for software updates and minor software enhancements to
Medtronic Model 9986 Desktop/ Baseline Operating System Software (BOSS) Version 2.6 for the Medtronic Model 2090 CareLink Programmer.
P100010/S015
4/12/12
Real-Time
Arctic Front CryoCatheter System Medtronic CryoCath LP
Mounds View, MN
55112
Approval for catheter changes to increase the uniformity of the distal balloon surface temperature (increased number of refrigerant ports on the injection tube coil, more distal position of the injection tube, increased refrigerant flow on the 28mm balloon), to add new visual marker on the catheter shaft and to implement additional minor changes to the design and labeling.
P100014/S005
4/24/12
180-Day
Solesta Injectable Gel Salix Pharmaceuticals, Inc.
Edison, NJ
08817
Approval of the post-approval study protocol.
P100021/S011
4/27/12
180-Day
Endurant II Stent Graft System Medtronic Vascular
Santa Rosa, CA
95403
Approval for a modified version of the Endurant Stent Graft System. The
Endurant II Stent Graft System is indicated for the endovascular treatment of infrarenal
abdominal aortic or aorto-iliac aneurysms having adequate iliac/
femoral access that is compatible
with vascular access techniques, devices and/or accessories; proximal neck length of ≥ 10 mm:
infrarenal neck angulation of ≤ 60°; distal fixation length of ≥ 15 mm; aortic neck diameters with
a range of
19-32 mm; iliac diameters with a range of 8-25 mm and morphology suitable for aneurysm repair.
P100023/S013
4/24/12
135-Day
ION Paclitaxel-Eluting Platinum Chromium Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Approval for revisions to guidewire visual acceptance criteria.
P100023/S030
4/5/12
135-Day
ION (TAXUS Element) Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire) Boston Scientific Corporation
Maple Grove, MN
55311
Approval for various cycle time reductions.
P100028/S002
4/30/12
Real-Time
Formula Balloon-Expandable Renal Stent System Cook, Inc.
Bloomington, IN
47402
Approval for the 4 mm version of the stent to be used with the Formula 414 Rx delivery system.
P100029/S011
4/13/12
Special
Trifecta™ Valve St. Jude Medical
St. Paul, MN
55117
Approval for revising the instruction regarding “suture tails”.
P100041/S002
4/6/12
180-Day
Edwards Sapien Transcatheter Heart Valve Edwards Lifesciences, LLC.
Irvine, CA
92614
Approval of the post-approval study protocol.
P110010/S005
4/5/12
135-Day
PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Approval for various cycle time reductions.

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

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P800019/S013
4/23/12
CYBERLITH Boston Scientific Corporation
St. Paul, MN
55112
Implementation of a new acceptance methodology at the quality system level.
P810031/S044
4/18/12
Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon, Healon GV, and Healon5 Products Abbott Medical Optics, Inc.
Santa Ana, CA
92705
Change to replace reusable glass sample tubes with disposable polypropylene sample tubes in the sodium hyaluronate test method.
P820022/S005
4/23/12
CYBERTACH Pulse Generator System Boston Scientific Corporation
St. Paul, MN
55112
Implementation of a new acceptance methodology at the quality system level.
P830026/S080
4/23/12
COSMOS Boston Scientific Corporation
St. Paul, MN
55112
Implementation of a new acceptance methodology at the quality system level.
P830060/S070
4/23/12
VENTAK Automatic Implantable Cardioverter Defibrillator (AICD) System Family Boston Scientific Corporation
St. Paul, MN
55112
Implementation of a new acceptance methodology at the quality system level.
P840001/S205
4/12/12
Pocket Adaptor Kits, Itrel 3, Synergy, Synergy Versitrel Medtronic Neuromodulation
Minneapolis, MN
55432
Add two alternate suppliers for the outer seal component.
P840001/S206
4/20/12
Restore Family of Implantable Neurostimulators Medtronic Neuromodulation
Minneapolis, MN
55432
Reduce the sample size for Parallel Gap Weld line testing on plated components.
P840001/S207
4/25/12
Restore Family of Implantable Neurostimulators Medtronic Neuromodulation
Minneapolis, MN
55432
Elimination of the parallel gap welding line testing with gold plating over base nickel components.
P840068/S050
4/23/12
DELTA/VISTA Families Boston Scientific Corporation
St. Paul, MN
55112
Implementation of a new acceptance methodology at the quality system level.
P860007/S024
4/23/12
INTERTACH Boston Scientific Corporation
St. Paul, MN
55112
Implementation of a new acceptance methodology at the quality system level.
P860057/S087
4/13/12
Carpentier-Edwards Perimount Pericardial Bioprosthesis Edwards Lifesciences, LLC
Irvine, CA
92614
New supplier for selvedge yarn.
P870056/S048
4/13/12
Carpentier-Edwards Perimount Pericardial Bioprosthesis Edwards Lifesciences, LLC
Irvine, CA
92614
New supplier for selvedge yarn.
P870077/S043
4/13/12
Carpentier-Edwards Perimount Pericardial Bioprosthesis Edwards Lifesciences, LLC
Irvine, CA
92614
New supplier for selvedge yarn.
P880047/S019
4/10/12
GYNECARE INTERCEED Absorbable Adhesion Barrier Ethicon, Inc.
Somerville, NJ
08876
Change in the contract laboratory used for dose audit testing.
P890003/S248
4/2/12
Prodigy Medtronic, Inc.
Mounds View, MN
55112
Various changes to the grommet manufacturing process.
P890061/S020
4/23/12
VENTAK P Automatic Implantable Cardioverter Defibrillator (AICD) System Family Boston Scientific Corporation
St. Paul, MN
55112
Implementation of a new acceptance methodology at the quality system level.
P900056/S113
4/19/12
Rotablator Rotational Angioplasty System Guidewire with WireClip Torquer Boston Scientific Corporation
Maple Grove, MN
55311
Implementation of an existing process to an existing sterilization equipment.
P910020/S027
4/23/12
RELAY Boston Scientific Corporation
St. Paul, MN
55112
Implementation of a new acceptance methodology at the quality system level.
P910073/S101
4/23/12
ENDOTAK Lead System Family Boston Scientific Corporation
St. Paul, MN
55112
Implementation of a new acceptance methodology at the quality system level.
P910077/S120
4/23/12
VENTAK PRx and VENTAK MINI Automatic Implantable Cardioverter Defibrillator (AICD)
Families
Boston Scientific Corporation
St. Paul, MN
55112
Implementation of a new acceptance methodology at the quality system level.
P920015/S089
4/2/12
“Y” Adaptor/Extender Kit Medtronic, Inc.
Mounds View, MN
55112
Various changes to the grommet manufacturing process.
P920047/S051
4/19/12
Blazer II Cardiac Ablation Catheter and Cable Boston Scientific Corporation
Maple Grove, MN
55311
Implementation of an existing process to an existing sterilization equipment.
P930014/S061
4/11/12
AcrySof and AcrySof ReSTOR Intraocular Lenses Alcon Research, Ltd.
Fort Worth, TX
76134
Use of a Five-Standard Pallet Load.
P930035/S021
4/23/12
VENTAK P2 Automatic Implantable Cardioverter Defibrillator (AICD) System Family Boston Scientific Corporation
St. Paul, MN
55112
Implementation of a new acceptance methodology at the quality system level.
P930039/S067
4/4/12
CapSureFix Lead, CapSureFix Novus Lead,Vitatron Crystalline Leads Medtronic, Inc.
Mounds View, MN
55112
Addition of two alternate suppliers for the manufacturer of silicone components.
P940008/S029
4/23/12
RES-Q/RES-Q MICRON Pulse Generator System Families Boston Scientific Corporation
St. Paul, MN
55112
Implementation of a new acceptance methodology at the quality system level.
P940031/S072
4/23/12
VIGOR DR/SR, DISCOVERY, MERIDIAN Families Boston Scientific Corporation
St. Paul, MN
55112
Implementation of a new acceptance methodology at the quality system level.
P950001/S023
4/23/12
SELUTE Lead System Family Boston Scientific Corporation
St. Paul, MN
55112
Implementation of a new acceptance methodology at the quality system level.
P950029/S067
4/19/12
Reply and Esprit SR/DR Sorin CRM USA, Inc.
Plymouth, MN
55441
Alternate method for a hybrid module wire bonding process.
P960004/S051
4/23/12
THINLINE/ FINELINE Family of Endocardial Pacing Leads Boston Scientific Corporation
St. Paul, MN
55112
Implementation of a new acceptance methodology at the quality system level.
P960006/S033
4/23/12
THINLINE/ FINELINE Family of Endocardial Pacing Leads Boston Scientific Corporation
St. Paul, MN
55112
Implementation of a new acceptance methodology at the quality system level.
P960009/S137
4/12/12
1x4 Pocket Adaptor Kit, 2x4 Pocket Adaptor Kit, Activa SC, Kinetra, Soletra Medtronic Neuromodulation
Minneapolis, MN 55432
Add two alternate suppliers for the outer seal component.
P960009/S138
4/20/12
Activa Family of Implantable Neurostimulators Medtronic Neuromodulation
Minneapolis, MN
55432
Reduce the sample size for Parallel Gap Weld line testing on plated components.
P960009/S139
4/25/12
Activa Family of Implantable Neurostimulators Medtronic Neuromodulation
Minneapolis, MN
55432
Elimination of the parallel gap welding line testing with gold plating over base nickel components.
P960040/S255
4/11/12
Incepta ICD, Energen ICD, Punctua ICD Boston Scientific Corporation
St. Paul, MN
55112
Change to the thermal processing of components and a change in suppliers.
P960040/S0256
4/23/12
SWEET TIP Rx, SWEET PICOTIP Rx, and FLEXTEND Lead System Families Boston Scientific Corporation
St. Paul, MN
55112
Implementation of a new acceptance methodology at the quality system level.
P960043/S077
4/10/12
Perclose A T 6F & Perclose Proglide Abbott Vascular
Redwood City, CA
94063
Change in final acceptance tensile testing activities.
P960043/S078
4/27/12
Perclose Proglide Suture Medicated Closure System Abbott Vascular, Inc.
Redwood City, CA
94063
Add an alternate supplier for detachable needles.
D970003/S134
4/23/12
PULSAR, PULSAR MAX, INSIGNIA, ALTRUA Families Boston Scientific Corporation
St. Paul, MN
55112
Implementation of a new acceptance methodology at the quality system level.
P970003/S147
4/13/12
VNS Therapy System Cyberonics, Inc.
Houston, TX
77058
Introduction of an additional receiving inspection for the torque wrench that is packaged with the VNS Therapy System Generators.
P970004/S130
4/12/12
InterStim Medtronic Neuromodulation
Minneapolis, MN
55432
Add two alternate suppliers for the outer seal component.
P970004/S131
4/20/12
InterStim II Implantable Neurostimulator Medtronic Neuromodulation
Minneapolis, MN
55432
Reduce the sample size for Parallel Gap Weld line testing on plated components.
P970004/S132
4/25/12
InterStim II Implantable Neurostimulator Medtronic Neuromodulation
Minneapolis, MN
55432
Elimination of the parallel gap welding line testing with gold plating over base nickel components.
P980003/S035
4/19/12
Chilli II Cooled Ablation Catheter and Cable Boston Scientific Corporation
Maple Grove, MN
55311
Implementation of an existing process to an existing sterilization equipment.
P980016/S342
4/2/12
EnTrust, Intrinsic, Marquis, Maximo, Maximo II, Protecta, Protecta XT,
Secura, Virtuoso, and Virtuoso II
Medtronic, Inc.
Mounds View, MN
55112
Removal of parallel gap welding line testing for select plated components.
P980016/S344
4/2/12
EnTrust ICD, Intrinsic ICD, Marquis DR ICD, Marquis VR ICD, Maximo DR ICD, Maximo II ICD, Maximo II M4, Maximo VR ICD, Protecta ICD, Protecta M4, Protecta XT ICD, Protecta XT M4, Secura ICD,
Secura M4, Virtuoso ICD, Virtuoso II DR/VR ICD
Medtronic, Inc.
Mounds View, MN
55112
Various changes to the grommet manufacturing process.
P980016/S345
4/4/12
Maximo VR ICD Medtronic, Inc.
Mounds View, MN
55112
Addition of two alternate suppliers for the manufacturer of silicone components.
P980016/S346
4/23/12
Maximo II DF4, Maximo II ICD, Protecta DF4, Protecta ICD, Protecta XT DF4, Protecta XT ICD, Secura DF4, Secura ICD, Virtuoso II DR/VR ICD Medtronic, Inc.
Mounds View, MN
55112
Change to the hybrid burn-in time.
P980022/S114
4/4/12
Paradigm REAL-Time Continuous Glucose Monitoring System and
Paradigm REAL-Time Revel Continuous Glucose Monitoring System
Medtronic MiniMed
Northridge, CA
91325
Use of an alternative supercapacitor due to a supply chain problem. The
supercapacitor 1037110-003 (NEC P/N: FGH0H154ZF-H5E) will replace 1037110-002 (NEC
P/N: FGH0H154ZF-LE) for the Paradigm REAL-Time Insulin Pump (Models MMT-522, -522K, -722, -722K) and Paradigm REAL-Time Revel Insulin Pump (Models MMT -523, -523K, -723, -723K). The Paradigm Real-Time Pump is a component of the Paradigm REAL-Time Continuous
Glucose Monitoring System. The Paradigm REAL-Time Revel Pump is a component of the
Paradigm REAL-Time Revel Continuous Glucose Monitoring System.
P980035/S263
4/2/12
Adapta, Advisa, EnRhythm, Relia, Sensia and Versa Medtronic, Inc.
Mounds View, MN
55112
Removal of parallel gap welding line testing for select plated components.
P980035/S265
4/2/12
Adapta, Adapta L, Adapta S, Sensia L, Sensia, Versa IPG, Advisa DR IPG, EnRhythm IPG, Relia IPG Medtronic, Inc.
Mounds View, MN
55112
Various changes to the grommet manufacturing process.
P980035/S266
4/4/12
Adapta, Adapta L, Adapta S, Sensia L, Sensia Versa IPG Medtronic, Inc.
Mounds View, MN
55112
Addition of two alternate suppliers for the manufacturer of silicone components.
P980035/S267
4/25/12
EnRhythm IPG Medtronic, Inc.
Mounds View, MN
55112
Modify the Electronically Erasable Programmable Read-Only Memory (EEPROM) Status byte test requirement.
P980043/S035
4/13/12
Hancock II Porcine Bioprosthesis Medtronic, Inc.
Santa Ana, CA
92705
Software modification to the stent machining process.
P980049/S072
4/19/12
Paradym VR/DR Sorin CRM USA, Inc.
Plymouth, MN
55441
Alternate method for a hybrid module wire bonding process.
P990001/S102
4/2/12
Vitatron DA+
C-Series IPGs and Vitatron DA+
T-Series IPGs
Medtronic, Inc.
Mounds View, MN
55112
Removal of parallel gap welding line testing for select plated components.
P990001/S103
4/2/12
Vitatron C20 SR IPG, Vitatron C60 DR IPG, Vitatron T20 SR IPG,
Vitatron T60 DR IPG
Medtronic, Inc.
Mounds View, MN
55112
Various changes to the grommet manufacturing process.
P990064/S042
4/13/12
Mosaic Porcine Bioprosthesis Medtronic, Inc.
Santa Ana, CA
92705
Software modification to the stent machining process.
P000006/S028
4/19/12
Titan Inflatable Penile Prosthesis Coloplast Corporation
Minneapolis, MN
55411
Change in the sterilization load configuration for the surgical products.
P000007/S030
4/13/12
Carpentier-Edwards Perimount Pericardial Bioprosthesis Edwards Lifesciences, LLC
Irvine, CA
92614
New supplier for selvedge yarn.
P000029/S071
4/19/12
Deflux Injectable Gel Salix Pharmaceuticals, Inc.
Raleigh, NC
27615
Additional laboratory for analytical testing.
P000029/S072
4/12/12
Deflux Injectable Gel Salix Pharmaceuticals, Inc.
Raleigh, NC
27617
Addition of the possibility to store samples for bioburden analysis in a refrigerator at a temperature of 5 degree Celsius for up to 18 hours before analysis.
P000036/S009
4/12/12
Dermagraft Advanced BioHealing, Inc.
LaJolla, CA
92037
Additional 50-Watt laser system for cutting Dermagraft final product samples.
P000036/S010
4/13/12
Dermagraft Advanced BioHealing, Inc.
LaJolla, CA
92037
Change in the media bag size.
P010012/S285
4/11/12
Incepta CRT-D, Energen CRT-D, Punctua CRT-D Boston Scientific Corporation
St. Paul, MN
55112
Change to the thermal processing of components and a change in suppliers.
P010012/S286
4/23/12
CONTAK CD, LIVIAN, COGNIS, ENERGEN, PUNCTUA, and
INCEPT A Automatic Implantable Cardiac Resynchronization Therapy Defibrillator System Families and ACUITY Spiral and EASYTRAK and
ACUITY Spiral Lead Systems
Boston Scientific Corporation
St. Paul, MN
55112
Implementation of a new acceptance methodology at the quality system level.
P010015/S156
4/2/12
Consulta CRT-P and Syncra CRT-Ps Medtronic, Inc.
Mounds View, MN
55112
Removal of parallel gap welding line testing for select plated components.
P010015/S158
4/2/12
Consulta CRT-P, Syncra CRT-P Medtronic, Inc.
Mounds View, MN
55112
Various changes to the grommet manufacturing process.
P010020/S022
4/26/12
Acticon Neosphincter American Medical Systems
Minnetonka, MN
55343
 
Implementation of additional mold press equipment and change in qualified supplier for a spring component.
P010031/S295
4/2/12
Concerto, Concerto II, Consulta, InSync II Marquis, InSync III Marquis InSync Maximo, InSync Sentry, Maximo II, Protecta and Protecta XT Medtronic, Inc.
Mounds View, MN
55112
Removal of parallel gap welding line testing for select plated components.
P010031/S297
4/2/12
Concerto ICD, Concerto II CRT-D, Consulta, Consulta DF4, InSync III
Marquis ICD, InSync Maximo ICD, Maximo II CRT-D, Maximo II M4, Protecta
CRT-D, Protecta M4, Protecta XT CRT-D, Protecta XT M4
Medtronic, Inc.
Mounds View, MN
55112
Various changes to the grommet manufacturing process.
P010031/S298
4/23/12
Concerto II CRT-D, Consulta, Consulta DF4, Maximo II CRT-D, Maximo
II DF4, Protecta CRT-D, Protecta DF4, Protecta XT CRT-D, Protecta XT DF4
Medtronic, Inc.
Mounds View, MN
55112
Change to the hybrid burn-in time.
P010032/S049
4/25/12
Implantable Pulse Generators, Percutaneous and Paddle Leads, Lead Extensions and Accessories St. Jude Medical
Plano, TX
75024
Sterilization manufacturing process changes for St. Jude Medical Neuromodulation Division products.
P010041/S032
4/13/12
Carpentier-Edwards Perimount Pericardial Bioprosthesis Edwards Lifesciences, LLC
Irvine, CA
92614
New supplier for selvedge yarn.
P010047/S018
4/20/12
Progel Pleural Air Leak Sealant Neomend, Inc.
Irvine, CA
92618
Implement an Automated Optical Inspection System in addition to a current manual inspection.
P020004/S071
4/27/12
Gore Excluder AAA Endoprosthesis W.L. Gore & Associates, Inc.
Phoenix, AZ
85085
Expansion of the operating parameters for an automated film wrapping machine.
P020009/S082
4/19/12
Express 2 Monorail and Over-the-Wire Boston Scientific Corporation
Maple Grove, MN
55311
Implementation of an existing process to an existing sterilization equipment.
P020025/S033
4/19/12
Blazer II XP Cardiac Ablation Catheter and Cable Boston Scientific Corporation
Maple Grove, MN
55311
Implementation of an existing process to an existing sterilization equipment.
P020050/S007
4/11/12
ALLEGRETTO WAVE Alcon Research, Ltd.
Fort Worth, TX
76134
Approval of a PMA supplement for the following three changes from the Annual Report, 2011: 1) a lternate source supplier for ventilator;
2) modified packaging of optical elements: and
3) new supplier for smart cards.
P030005/S082
4/23/12
CONTAK RENEWAL TR Cardiac Resynchronization Therapy Pacemaker (CRT-P) System Family Boston Scientific Corporation
St. Paul, MN
55112
Implementation of a new acceptance methodology at the quality system level.
P030008/S007
4/11/12
ALLEGRETTO WAVE Eye-Q Excimer Laser Systems Alcon Research, Ltd.
Fort Worth, TX
76134
Approval of a PMA supplement for the following three changes from the Annual Report, 2011: 1) a lternate source supplier for ventilator;
2) modified packaging of optical elements: and
3) new supplier for smart cards.
P030017/S131
4/4/12
Precision Spinal Cord Stimulation (SCS) System Boston Scientific Neuromodulation
Valencia, CA
91355
Move the charger assembly process from a vendor, to in-house and install new equipment to implement the change.
P030025/S095
4/19/12
TAXUS Express² Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Implementation of an existing process to an existing sterilization equipment.
P030036/S042
4/4/12
SelectSecure Lead Medtronic, Inc.
Mounds View, MN
55112
Addition of two alternate suppliers for the manufacturer of silicone components.
P040016/S085
4/19/12
VeriFLEX (Libertè) Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Implementation of an existing process to an existing sterilization equipment.
P040020/S041
4/11/12
AcrySof and AcrySof ReSTOR Intraocular Lenses Alcon Research, Ltd.
Fort Worth, TX
76134
Use of a Five-Standard Pallet Load.
P040023/S020
4/26/12
Duraloc Option Ceramic Hip System DePuy Orthopaedics
Warsaw, IN
46582
Changes to the sterile barrier package sealing process used for the ceramic femoral heads and acetabular liners.
P040043/S046
4/4/12
GORE TAG Thoracic Endoprosthesis W.L. Gore & Associates, Inc.
Flagstaff, AZ
860001
Addition of new equipment to the stent winding process.
P050042/S016
4/13/12
ARCHITECT Anti-HCV Abbott Laboratories
Abbott Park, IL
60064
Add a peroxide level quality control test for all incoming vendor lots of detergent.
P050046/S014
4/23/12
ACUITY Steerable Lead System Family Boston Scientific Corporation
St. Paul, MN
55112
Implementation of a new acceptance methodology at the quality system level.
P050047/S024
4/16/12
JUVÉDERM Hyaluronate Gel Implants Allergan
Goleta, CA
93117
Review to increase the number of syringes dried in the drying ovens and harmonize the number of syringes dried per drying cycle with the number of syringes sterilized per sterilization cycle.
P060002/S025
4/27/12
Bard Flair Endovascular Stent Graft C.R. Bard, Inc.
Tempe, AZ
85281
Updates to existing raw material inspection equipment and the addition of new raw material inspection equipment.
P060006/S025
4/19/12
Express SD Monorail Premounted Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Implementation of an existing process to an existing sterilization equipment.
P060008/S086
4/19/12
TAXUS Libertè Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Implementation of an existing process to an existing sterilization equipment.
P060027/S039
4/19/12
Paradym CRT Sorin CRM USA, Inc.
Plymouth, MN
55441
Alternate method for a hybrid module wire bonding process.
P070014/S031
4/27/12
LifeStent Vascular Stent C.R. Bard, Inc.
Tempe, AZ
85281
Updates to existing raw material inspection equipment and the addition of new raw material inspection equipment.
P070026/S005
4/26/12
Ceramax Total Hip System DePuy Orthopaedics
Warsaw, IN
46582
Changes to the sterile barrier package sealing process used for the ceramic femoral heads and acetabular liners.
P080007/S013
4/27/12
E-Luminexx Vascular Stent C.R. Bard, Inc.
Tempe, AZ
85281
Updates to existing raw material inspection equipment and the addition of new raw material inspection equipment.
P080023/S013
4/13/12
ARCHITECT CORE Abbott Laboratories
Abbott Park, IL
60064
Add a peroxide level quality control test for all incoming vendor lots of detergent.
P080023/S014
4/13/12
ARCHITECT CORE Abbott Laboratories
Abbott Park, IL
60064
Test method change for bioburden evaluation of an intermediate used in the manufacture of ARCHITECT CORE calibrator and controls.
P080025/S027
4/12/12
InterStim Medtronic Neuromodulation
Minneapolis, MN
55432
Add two alternate suppliers for the outer seal component.
P080025/S028
4/20/12
InterStim II Implantable Neurostimulators Medtronic Neuromodulation
Minneapolis, MN
55432
Reduce the sample size for Parallel Gap Weld line testing on plated components.
P080025/S029
4/25/12
InterStim II Implantable Neurostimulator Medtronic Neuromodulation
Minneapolis, MN
55432
Elimination of the parallel gap welding line testing with gold plating over base nickel components.
P090002/S003
4/26/12
CoMplete Acetabular Hip System DePuy Orthopaedics
Warsaw, IN
46582
Changes to the sterile barrier package sealing process used for the ceramic femoral heads and acetabular liners.
P090013/S056
4/2/12
Revo MRI Medtronic, Inc.
Mounds View, MN
55112
Removal of parallel gap welding line testing for select plated components.
P090013/S057
4/2/12
Revo MRI IPG Medtronic, Inc.
Mounds View, MN
55112
Various changes to the grommet manufacturing process.
P090013/S058
4/4/12
CapSureFix MRI Lead Medtronic, Inc.
Mounds View, MN
55112
Addition of two alternate suppliers for the manufacturer of silicone components.
P090013/S060
4/25/12
REVO MRI Medtronic, Inc.
Mounds View, MN
55112
Modify the Electronically Erasable Programmable Read-Only Memory (EEPROM) Status byte test requirement.
P090028/S002
4/16/12
VITROS Immunodiagnostic Products HBeAG Reagent Pack and Calibrator Ortho-Clinical Diagnostics, Inc.
Rochester, NY
14626
Change in the timing of the QA Release Tests from sequential to concurrent.
P100001/S001
4/16/12
VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator Ortho-Clinical Diagnostics, Inc.
Rochester, NY
14626
Change in the timing of the QA Release Tests from sequential to concurrent.
P100010/S016
4/4/12
Arctic Front Cardiac CryoAblation Catheters Medtronic CryoCath LP
Mounds View, MN
55112
Change to the application of adhesive and the addition of an inspection tool.
P100014/S007
4/12/12
Solesta Salix Pharmaceuticals, Inc.
Raleigh, NC
27617
Addition of the possibility to store samples for bioburden analysis in a refrigerator at a temperature of 5 degree Celsius for up to 18 hours before analysis.
P100021/S014
4/23/12
Endurant Stent Graft Systems Medtronic Vascular
Santa Rosa, CA
95403
Automation of the etching and heat setting processes and a change in solution mixing location at a component supplier.
P100023/S037
4/13/12
ION Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Alternative process for the manufacturing of catheter assemblies.
P100023/S039
4/19/12
ION Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Implementation of an existing process to an existing sterilization equipment.
P100029/S012
4/26/12
Trifecta Valve St. Jude Medical, Inc.
St. Paul, MN
55117
Change to the manufacturing solutions used during tissue processing.
P110010/S008
4/3/12
PROMUS Element Plus Everolimus- Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Manufacturing equipment change for the drug spraying process.
P110010/S009
4/13/12
PROMUS Element Plus Everolimus Eluting Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Alternative process for the manufacturing of catheter assemblies.
P110010/S011
4/19/12
PROMUS Element Plus Everolimus- Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Implementation of an existing process to an existing sterilization equipment.
P110010/S012
4/13/12
PROMUS Element Plus Everolimus-Eluting Chromium Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Implementation of a new laser system for sorting extruded balloon tubes.
P110019/S016
4/9/12
XIENCE PRIME and XIENCE PRIME LL Everolimus-Eluting Coronary Stent Systems Abbott Vascular
Temecula, CA
92591
Modification of sampling for degradation products.
P110019/S017
4/27/12
XIENCE PRIME Everolimus-Eluting Coronary Stent System and XIENCE PRIME LL Everolimus-Eluting Coronary Stent System Abbott Vascular
Temecula, CA
92591
Change to the dislodgment testing sampling plan.

Summary of PMA Originals & Supplements Approved
Originals: 4
Supplements: 120

Summary of PMA Originals Under Review
Total Under Review: 66
Total Active: 29
Total On Hold: 37
Number Greater Than 180 Days: 1

Summary of PMA Supplements Under Review
Total Under Review: 570
Total Active: 382
Total On Hold: 188
Number Greater Than 180 Days: 7

Summary of All PMA Submissions Received
Originals: 3
Supplements: 79

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 120
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 113.2
FDA Time: 92.7 Days MFR Time: 20.5 Days