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.

APPLICATION NUMBER / DATE of APPROVAL

DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION / INDICATIONS
P050027 5/28/10	Karl Storz Photodynamic Diagnostic D-Light C (PDD) System	Karl Storz Endoscopy-America, Inc. El Segundo, CA 90245	Approval for the Karl Storz Photodynamic Diagnostic D-Light C (PDD) System. The Karl Storz Photodynamic Diagnostic D-Light C (PDD) System in combination with the optical imaging drug Cysview® (hexaminolevulinate hydrochloride) for Intravesical Solution is indicated for photodynamic blue light cystoscopy, as an adjunct to white light cystoscopy for the detection of non-muscle invasive papillary cancer of the bladder in patients suspected or known to have the lesion on the basis of a prior cystoscopy.

APPLICATION NUMBER / DATE of APPROVAL

DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION / INDICATIONS
P810031/S037 5/20/10 Real-Time	Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon®, Healon GV® and Healon5®	Abbott Medical Optics, Inc. Santa Ana, CA 92705	Approval for a change in packaging for two individual blister tray packs (Healon® & Healon5®) to be packed in a single carton box.
P820003/S093 5/11/10 Real-Time	Various Device Families	Medtronic, Inc. Mounds View, MN 55112	Approval for enhancements to the Model 9986 Software. The Model 9986 Software is the Desktop/Baseline Operating System Software (BOSS) for the Medtronic Model 2090 CareLink Programmer.
P850051/S072 5/11/10 Real-Time	Various Device Families	Medtronic, Inc. Mounds View, MN 55112	Approval for enhancements to the Model 9986 Software. The Model 9986 Software is the Desktop/Baseline Operating System Software (BOSS) for the Medtronic Model 2090 CareLink Programmer.
P850079/S047 5/3/10 180-Day	CLEAR SOFT (methafilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear	CooperVision Norfolk, VA 23507	Approval for the trade name CLEAR SOFT. The device, as modified, will be marketed under the trade name CLEAR SOFT and is indicated for: CLEAR SOFT Sphere (methafilcon A) Soft Contact lenses are indicated for the correction of ametropia (myopia or hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of -2.00 diopters or less that does not interfere with visual acuity. CLEAR SOFT Toric (methafilcon A) Soft Contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -5.00 diopters. The CLEAR SOFT (methafilcon A) Soft (Hydrophilic) Contact Lenses have been approved for extended wear for up to 6 nights/7 days of continuous wear. It is recommended that the contact lens wearer first be evaluated on a daily wear schedule. If successful, then a gradual introduction of extended wear can be followed as determined by the prescribing Eye Care Practitioner. Eye care practitioners may prescribe the lens for frequent replacement wear with cleaning, disinfecting and scheduled replacements.
P860019/S252 5/11/10 Real-Time	Quantum Maverick OTW, Apex OTW, Maverick OTW, and Maverick XL Monorail PTCA Dilatation Catheters	Boston Scientific Corporation Maple Grove, MN 55311	Approval for material and specification changes to the strain relief.
P890003/S186 5/11/10 Real-Time	Various Device Families	Medtronic, Inc. Mounds View, MN 55112	Approval for enhancements to the Model 9986 Software. The Model 9986 Software is the Desktop/Baseline Operating System Software (BOSS) for the Medtronic Model 2090 CareLink Programmer.
P890003/S188 5/11/10 Real-Time	Medtronic® CareLink Device Data Management Application (DDMA) Model 2491	Medtronic, Inc. Mounds View, MN 55112	Approval for updates made to the Programmer Application Software Model 9995 and the CareLink Device Data Management Application (DDMA) in response to adverse field events.
P900061/S087 5/11/10 Real-Time	Various Device Families	Medtronic, Inc. Mounds View, MN 55112	Approval for enhancements to the Model 9986 Software. The Model 9986 Software is the Desktop/Baseline Operating System Software (BOSS) for the Medtronic Model 2090 CareLink Programmer.
P910023/S226 5/7/10 180-Day	Fortify VR/DR	St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086	Approval for the Fortify VR/DR pulse generators.
P910077/S104 5/19/10 Real-Time	Zoom Latitude Programmer	Boston Scientific CRM St. Paul, MN 55112	Approval for a minor design change to the Model 3120 Zoom Latitude programmer and an alternate supplier for the hard drive component in the programmer.
P930022/S011 5/11/10 Real-Time	Various Device Families	Medtronic, Inc. Mounds View, MN 55112	Approval for enhancements to the Model 9986 Software. The Model 9986 Software is the Desktop/Baseline Operating System Software (BOSS) for the Medtronic Model 2090 CareLink Programmer.
P950037/S072 5/7/10 180-Day	Evia/Entovis Pulse Generators	Biotronik, Inc. Lake Oswego, OR 97035	Approval for the Evia/Entovis Pulse Generators.
P960013/S058 5/19/10 Real-Time	OptiSense	St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342	Approval for new stylets to be included in the OptiSense Model 1999 lead package.
P970003/S109 5/18/10 Special	VNS Therapy System	Cyberonics, Inc. Houston, TX 77058	Approval for a labeling modification regarding the internal clock reset in the Model 100, 101, 102 and 102R Implanted pulse Generators (IPGs).
P970008/S049 5/13/10 Real-Time	Urologix Targis® System	Urologix, Inc. Minneapolis, MN 55447	Approval to replace an obsolete touchscreen and modify the microwave generator to improve design margins.
P970012/S065 5/11/10 Real-Time	Various Device Families	Medtronic, Inc. Mounds View, MN 55112	Approval for enhancements to the Model 9986 Software. The Model 9986 Software is the Desktop/Baseline Operating System Software (BOSS) for the Medtronic Model 2090 CareLink Programmer.
P970021/S028 5/13/10 180-Day	Gynecare Thermachoice III Uterine Balloon Therapy System	Ethicon, Inc. Somerville, NJ 08876	Approval for updated professional labeling to reflect the results of the Post-Approval Study required as a condition of approval to Supplement 14.
P970051/S057 5/14/10 135-Day	Nucleus 24 Cochlear Implant System	Cochlear Americas Centennial, CO 80111	Approval for a change to the material used in the manufacturing of the microphone protector cover for the CP810 Sound Processor.
P980016/S232 5/11/10 Real-Time	Various Device Families	Medtronic, Inc. Mounds View, MN 55112	Approval for enhancements to the Model 9986 Software. The Model 9986 Software is the Desktop/Baseline Operating System Software (BOSS) for the Medtronic Model 2090 CareLink Programmer.
P980016/S234 5/11/10 Real-Time	Medtronic® Secura® DR/VR D224DRG/ D224VRC, Maximo® DR/VR D284DRG/ D284VRC, Virtuoso II DR/VR D274DRG/ D274VRC Implantable Cardioverter Defibrillators	Medtronic, Inc. Mounds View, MN 55112	Approval for updates made to the Programmer Application Software Model 9995 and the CareLink Device Data Management Application (DDMA) in response to adverse field events.
P980035/S161 5/11/10 Real-Time	Various Device Families	Medtronic, Inc. Mounds View, MN 55112	Approval for enhancements to the Model 9986 Software. The Model 9986 Software is the Desktop/Baseline Operating System Software (BOSS) for the Medtronic Model 2090 CareLink Programmer.
P980050/S047 5/11/10 Real-Time	Various Device Families	Medtronic, Inc. Mounds View, MN 55112	Approval for enhancements to the Model 9986 Software. The Model 9986 Software is the Desktop/Baseline Operating System Software (BOSS) for the Medtronic Model 2090 CareLink Programmer.
P990001/S064 5/11/10 Real-Time	Various Device Families	Medtronic, Inc. Mounds View, MN 55112	Approval for enhancements to the Model 9986 Software. The Model 9986 Software is the Desktop/Baseline Operating System Software (BOSS) for the Medtronic Model 2090 CareLink Programmer.
P990020/S039 5/21/10 180-Day	ANEURx AAAdvantage Stent Graft Delivery System	Medtronic Vascular Santa Rosa, CA 95403	Approval for a sterilization site located at Isotron Ireland, LTD., in Offaly, Ireland.
P990027/S010 5/18/10 180-Day	Bausch & Lomb Technolas T217z Zyoptix Laser System	Biomed Research, Inc. Lutz, FL 33558	Approval for the following changes: 1) Removal of a redundant fluence test; 2) Introduction of a new scanner system from GSI to the laser System: 3) Extrapolation of the Wavefront data in the Diagnostic Zywave Software; 4) New ZRS (Zyoptix Remote Support) Software to monitor the performance of the laser and diagnostic devices remotely via the internet; 5) Modification of the ZRS to include TruLink, an enhancement to the ZRS system; 6) Introduction of a new OP field illumination in the laser system; 7) Change of the video chip in the CCD Lenslet Camera DMK4002-IR; and 8) Change in the supplier of the temperature control unit in the laser system.
P990038/S013 5/21/10 135-Day	ETI-MAK-2 PLUS & ETI-MAK-2 PLUS HBsAg Confirmatory Test	DiaSorin, Inc. Stillwater, MN 55082	Approval for changing BSA raw material.
P990041/S012 5/21/10 135-Day	ETI-AB-EBK PLUS	DiaSorin, Inc. Stillwater, MN 55082	Approval for changing BSA raw material.
P990042/S009 5/21/10 135-Day	ETI-AB-AUK PLUS	DiaSorin, Inc. Stillwater, MN 55082	Approval for changing BSA raw material.
P990043/S013 5/21/10 135-Day	ETI-EBK PLUS	DiaSorin, Inc. Stillwater, MN 55082	Approval for changing BSA raw material.
P990044/S010 5/21/10 135-Day	ETI-CORE-IGMK PLUS	DiaSorin, Inc. Stillwater, MN 55082	Approval for changing BSA raw material.
P990045/S010 5/21/10 135-Day	ETI-AB-COREK PLUS	DiaSorin, Inc. Stillwater, MN 55082	Approval for changing BSA raw material.
P990066/S035 5/20/10 180-Day	GE-Healthcare Senographe Essential Digital Mammography System	GE Healthcare Milwaukee, WI 53201	Approval for a modification to the amorphous silicon array design used in the detector of the Senographe Essential full field digital mammography system. The proposed modifications include the following: 1) Reducing the number of layers in the detector amorphous silicon array; 2) Change in the detector firmware to allow the detector configuration to be communicated to the system Image Detector Controller (IDC); 3) IDC software to automatically determine if a detector with the proposed modification is installed on the system and properly select the proper configuration table; and 4) Corresponding changes in the incoming acceptance criteria testing station for the modified detector.
P000009/S035 5/7/10 180-Day	Evia/Entovis Pulse Generators	Biotronik, Inc. Lake Oswego, OR 97035	Approval for the Evia/Entovis Pulse Generators.
P000021/S013 5/19/10 180-Day	Dimension Vista® TPSA Flex® Reagent Cartridge	Siemens Healthcare Diagnostics, Inc. Newark, DE 19714	Approval for the following changes: 1) Detection technology from spectrophotometry to chemiluminesence; 2) Appropriate reagent process changes to accommodate chemiluminesence detection; 3) Usage on the Dimension Vista® 1500 System; 4) Usage on the Dimension Vista® 3000T System which consists of two Dimension Vista® 1500 Systems connected by a sample track transport mechanism; 5) Usage on the Dimension Vista® 1500 System connected to the StreamLab® analytical Workcell Laboratory Automation System; and 6) The new Dimension Vista® PSA Calibrator for use with the Dimension Vista® TPSA and FPSA methods. The device, as modified, will be marketed under the trade name Dimension Vista® TPSA Flex reagent cartridge and is indicated for the following uses: The TPSA method is an in vitro diagnostic test for the quantitative measurement of total prostate specific antigen (PSA) in human serum and plasma on the Dimension Vista® System: 1) As an aid in the detection of prostate cancer when used in conjunction with digital rectal exam (DRE) in men 50 years or older. Prostate biopsy is required for diagnosis of cancer. 2) As an aid in the management (monitoring) of prostate cancer patients. The Dimension Vista PSA calibrator will be marketed separately for use with the Dimension Vista TPSA Flex reagent and is indicated for the calibration of Total (TPSA) and Free (FPSA) Prostate Specific Antigen methods on the Dimension Vista® Systems.
P000021/S015 5/27/10 180-Day	Dimension TPSA Flex Reagent Cartridge	Siemens Healthcare Diagnostics, Inc. Newark, DE 19714	Approval for the Dimension TPSA Flex reagent cartridge on the Dimension EXL with LM System.
P000054/S024 5/17/10 Special	INFUSE® Bone Graft	Medtronic Sofamor Danek Memphis, TN 38132	Approval for changes to the patient information brochure.
P000058/S036 5/17/10 Special	INFUSE® Bone Graft/LT-Cage Lumbar Tapered Fusion Device	Medtronic Sofamor Danek Memphis, TN 38132	Approval for changes to the patient information brochure.
P010003/S015 5/12/10 Special	BioBlue® Surgical Adhesive	CryoLife, Inc. Kennesaw, GA 30144	Approval for clarification regarding one of the warnings in the Instructions for Use (IFU).
P010015/S082 5/11/10 Real-Time	Various Device Families	Medtronic, Inc. Mounds View, MN 55112	Approval for enhancements to the Model 9986 Software. The Model 9986 Software is the Desktop/Baseline Operating System Software (BOSS) for the Medtronic Model 2090 CareLink Programmer.
P010030/S019 5/21/10 Real-Time	LifeVest Wearable Defibrillator WCD 4000	Zoll Lifecor Corporation Pittsburgh, PA 15238	Approval for a component value change to the ECG electrode buffer boards to improve ECG amplifier common mode rejection.
P010031/S191 5/11/10 Real-Time	Various Device Families	Medtronic, Inc. Mounds View, MN 55112	Approval for enhancements to the Model 9986 Software. The Model 9986 Software is the Desktop/Baseline Operating System Software (BOSS) for the Medtronic Model 2090 CareLink Programmer.
P010031/S193 5/11/10 Real-Time	Medtronic® Consulta CRT-D D224TRK, Maximo® II CRT-D D284TRK, Concerto™ II D274TRK Implantable Cardioverter Defibrillators with Cardiac Resynchronization	Medtronic, Inc. Mounds View, MN 55112	Approval for updates made to the Programmer Application Software Model 9995 and the CareLink Device Data Management Application (DDMA) in response to adverse field events.
P020004/S049 5/5/10 135-Day	GORE EXCLUDER® AAA Endoprosthesis	W.L. Gore and Associates Flagstaff, AZ 86001	Approval for an expansion of the manufacturing environment.
P020004/S050 5/12/10 Real-Time	GORE EXCLUDER® AAA Endoprosthesis	W.L. Gore and Associates Flagstaff, AZ 86001	Approval for the removal of the center knot sleeve attachment.
P020009/S061 5/11/10 Real-Time	Express OTW Coronary Stent System	Boston Scientific Corporation Maple Grove, MN 55311	Approval for material and specification changes to the strain relief.
P020027/S009 5/17/10 180-Day	Dimension Vista® FPSA Flex® Reagent Cartridge	Siemens Healthcare Diagnostics, Inc. Newark, DE 19714	Approval for the following changes: 1) Detection technology from spectrophotometry to chemiluminesence; 2) Appropriate reagent process changes to accommodate chemiluminesence detection; 3) Usage on the Dimension Vista® 1500 System; 4) Usage on the Dimension Vista® 3000T System which consists of two Dimension Vista® 1500 Systems connected by a sample track transport mechanism; and 5) Usage on the Dimension Vista® 1500 System connected to the StreamLab® analytical Workcell Laboratory Automation System. The device, as modified, will be marketed under the trade name Dimension Vista® FPSA Flex reagent cartridge and is indicated for: The FPSA method for the Dimension Vista® System is an in vitro diagnostic test intended to quantitatively measure free prostate specific antigen (FPSA) in human serum and plasma. Measurements of FPSA are used in conjunction with total PSA (TPSA) method on Dimension Vista® System to calculate FPSA to TPSA ratio expressed as a percent FPSA. The percent FPSA is used as an aid in distinguishing prostate cancer from benign prostate conditions in men 50 years or older with TPSA of 4.0 to 1.0 ng/mL and DRE findings not suspicious for cancer. Prostate biopsy is required for diagnosis of cancer.
P020027/S010 5/27/10 180-Day	Dimension FPSA Flex Reagent Cartridge	Siemens Healthcare Diagnostics, Inc. Newark, DE 19714	Approval for the Dimension FPSA Flex reagent cartridge on the Dimension EXL with LM System.
P030017/S098 5/6/10 Real-Time	Precision® Spinal Cord Stimulation (SCS) System	Boston Scientific Neuromodulation Corp. Valencia, CA 91355	Approval for a consolidation of three separate instruction manuals (i.e., Physician Implant, Physician Lead, and Physician Surgical Lead Manuals) into a single manual, the Physician System Clinical manual.
P030025/S085 5/11/10 Real-Time	Taxus Express2 Coronary Stent System, Taxus Express2 Atom Paclitaxel-Eluting Coronary Stent System	Boston Scientific Corporation Maple Grove, MN 55311	Approval for material and specification changes to the strain relief.
P030054/S130 5/10/10 180-Day	QuickFlex µ Left Ventricular Lead	St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342	Approval for the QuickFlex µ Model 1258TLeft Ventricular Lead.
P030054/S141 5/7/10 180-Day	Unify CRT-D	St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086	Approval for the Unify CRT-D pulse generators.
P030054/S146 5/3/10 180-Day	Merlin Patient Care System Programmer Model 3650	St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086	Approval for: 1) The addition of the pacing systems analyzer (PSA) model EX3100. The model EX3100 also includes accessories: a) Merlin Antenna Adapter EX3190; b) Merlin Cable Adapter EX3170; and c) Merlin “M” Adapter EX3180; and 2) The addition of the Model 3330 version 10.1.1 software.
P040002/S027 5/12/10 Real-Time	PowerLink System	Endologix, Inc. Irvine, CA 92618	Approval for new PowerLink system models, including bifurcated devices with new lengths and diameters, limb extensions with new lengths, and aortic extensions with new lengths.
P040016/S054 5/11/10 Real-Time	VeriFLEX OTW Bare-Metal Coronary Stent System	Boston Scientific Corporation Maple Grove, MN 55311	Approval for material and specification changes to the strain relief.
P040034/S016 5/28/10 180-Day	DuraSeal® Dural Sealant System	Confluent Surgical, Inc. Bedford, MA 01730	Approval to update the contents of the DuraSeal Package Insert based on the results of the post-approval study.
P040043/S033 5/25/10 Real-Time	GORE TAG Thoracic Endoprosthesis	W.L. Gore & Associates, Inc. Flagstaff, AZ 86001	Approval for a new 22 mm constraining sleeve size to be used in the 40 mm diameter TAG device.
P050023/S024 5/7/10 180-Day	Evia/Entovis Pulse Generators	Biotronik, Inc. Lake Oswego, OR 97035	Approval for the Evia/Entovis Pulse Generators.
P050033/S008 5/24/10 Special	Elevess	Anika Therapeutics, Inc. Bedford, MA 01730	Approval for revision of the physician and patient labels to include updates on the post market adverse event experience with the device.
P060002/S006 5/18/10 180-Day	Flair Endovascular Stent Graft	C.R. Bard Tempe, AZ 85281	Approval of the post-approval protocol.
P060006/S006 5/28/10 180-Day	Express™ SD Renal Monorail™ Premounted Stent System	Boston Scientific Corporation Maple Grove, MN 55311	Approval for reinstatement of a secondary sterilization site formerly owned by Steris Isomedix Services, Inc. (Steris) located in Coventry, Rhode Island.
P060006/S010 5/11/10 Real-Time	Express™ SD Renal Monorail™ Premounted Stent System	Boston Scientific Corporation Maple Grove, MN 55311	Approval for material and specification changes to the strain relief.
P060008/S045 5/11/10 Real-Time	TAXUS® Liberté® OTW Paclitaxel-Eluting Coronary Stent System, Taxus Liberte Atom OTW Paclitaxel-Eluting Coronary Stent System	Boston Scientific Corporation Maple Grove, MN 55311	Approval for material and specification changes to the strain relief.
P060008/S047 5/17/10 Real-Time	TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System	Boston Scientific Corporation Maple Grove, MN 55311	Approval for MR compatibility labeling changes to the Directions for Use (DFU) and Patient Information Guide (PG) for the TAXUS Liberté Monorail (MR) and Over-the-Wire (OTW) Stent Delivery Systems.
P060040/S010 5/7/10 180-Day	Heartmate II Left Ventricular Assist System	Thoratec Corporation Pleasanton, CA 94588	Approval of the post-approval study protocol.
P070008/S011 5/7/10 180-Day	Evia/Entovis Pulse Generators	Biotronik, Inc. Lake Oswego, OR 97035	Approval for the Evia/Entovis Pulse Generators.

APPLICATION NUMBER / DATE of APPROVAL

DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION / INDICATIONS
P790007/S025 5/28/10	Hancock® I Low Porosity and Modified Orifice Valved Conduit	Medtronic, Inc. Santa Ana, CA 92705	Addition of Gorditos Meats as an alternate supplier.
P810046/S238 5/13/10	Voyager® NC Coronary Dilatation Catheter	Abbott Vascular, Inc. Temecula, CA 92591	Change in the extrusion process for the tubing used to manufacture the Voyager® NC Coronary Dilatation Catheter’s 3.50 mm through 5.00 mm balloons.
P830061/S051 5/19/10	CapSure Sense, Vitatron	Medtronic, Inc. Mounds View, MN 55112	Addition of a second source supplier of electrode components.
P840001/S152 5/20/10	Restore Implantable Stimulators	Medtronic Neuromodulation Minneapolis, MN 55432	Addition of the supplemental Automated Optical Inspection (AOI).
P840001/S153 5/27/10	RestoreULTRA Implantable Neurostimulator	Medtronic Neuromodulation Minneapolis, MN 55432	Change to qualify a connector rework process for the device manufacturing processes at Medtronic Puerto Rico Operations Company, Juncos, Puerto Rico.
P860004/S127 5/20/10	Personal Therapy Manager	Medtronic Neuromodulation Minneapolis, MN 55432	Addition of the supplemental Automated Optical Inspection (AOI).
P860019/S255 5/2710	Apex™ Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter	Boston Scientific Maple Grove, MN 55311	Alternate sterilization cycle to be used at Isotron, Tullamore, Ireland.
P870078/S009 5/28/10	Hancock® Porcine Bioprosthesis	Medtronic, Inc. Santa Ana, CA 92705	Addition of Gorditos Meats as an alternate supplier.
P890003/S190 5/14/10	Carelink Programmer	Medtronic, Inc. Mounds View, MN 55112	Change to the antenna support, manufacturing process changes related to the antenna support change, and changes to an antenna test.
P890064/S022 5/17/10	digene ® Hybrid Capture 2 (HC2) HPV DNA Test and digene® Hybrid Capture 2 (HC2) High Risk HPV DNA Test	Qiagen Gaithersburg, Inc. Gaithersburg, MD 20878	Change in supplier for the reagent in the device.
P890064/S023 5/17/10	digene ® Hybrid Capture 2 (HC2) HPV DNA Test and digene® Hybrid Capture 2 (HC2) High Risk HPV DNA Test	Qiagen Gaithersburg, Inc. Gaithersburg, MD 20878	Enabling the existing barcode reader configuration within the equipment software during the production of the device.
P890064/S024 5/17/10	digene ® Hybrid Capture 2 (HC2) HPV DNA Test and digene® Hybrid Capture 2 (HC2) High Risk HPV DNA Test	Qiagen Gaithersburg, Inc. Gaithersburg, MD 20878	Scale-up in the production of a component in the device.
P910073/S083 5/21/10	Reliance Family of Leads	Boston Scientific Corporation St. Paul, MN 55112	Replacement of existing automated measuring equipment.
P930039/S037 5/19/10	CapSureFix Novus, Vitatron	Medtronic, Inc. Mounds View, MN 55112	Addition of a second source supplier of electrode components.
P940031/S067 5/20/10	Discovery SR and DR	Boston Scientific Corporation St. Paul, MN 55112	Elimination of the outer sleeve wash step.
P950029/S052 5/26/10	Symphony, Rhapsody, Reply, Reply (V2), and Esprit Family of Pacemakers	ELA Medical, Inc. Plymouth, MN 55441	Change in location of the hybrid electronic module subcomponent manufacturing.
P950037/S080 5/13/10	Sterox S and Dextrus Family of Implantable Pacemaker Pulse Generators and Programmers	Biotronik, Inc. Lake Oswego, OR 97035	Change in packaging to the inner and outer bags of the sterilized stylet accessories.
P960009/S082 5/20/10	Activa Family of Implantable Stimulators	Medtronic Neuromodulation Minneapolis, MN 55432	Addition of the supplemental Automated Optical Inspection (AOI).
P960013/S059 5/13/10	Tendril, Tendril ST, Tendril STS, and Optisense Leads	St. Jude Medical Sylmar, CA 91342	Change in MCRD manufacturing process.
P960030/S030 5/13/10	Passive Plus, Isoflex S & P, and Isoflex Optim Leads	St. Jude Medical Sylmar, CA 91342	Change in MCRD manufacturing process.
P960040/S221 5/19/10	Confient and Vitality HE Families of Pulse Generators	Boston Scientific Corporation Cardiac Rhythm Management St. Paul, MN 55112	Plating change to the reed switch component.
P960040/S222 5/19/10	Ventak Prizm, Ventak Prizm 2, Vitality, Vitality HE, Vitality 2, Vitality AVT, and Confient Families of ICDs	Boston Scientific Corporation Cardiac Rhythm Management St. Paul, MN 55112	Multiple cleaning and component testing changes for the crystal oscillator component.
P960040/S223 5/20/10	Confient and Vitality Families of ICDs	Boston Scientific Corporation Cardiac Rhythm Management St. Paul, MN 55112	Changes in the suppliers for thin-film resistors.
P960043/S071 5/5/10	Perclose® AT 6F and Perclose® ProGlide™ Suture Medicated Closure Systems	Abbott Vascular, Inc. Redwood City, CA 94063	Addition of an alternate supplier for two overmolded components.
D970003/S118 5/19/10	Altrua Family of IPGs	Boston Scientific Corporation St. Paul, MN 55112	Changes for hybrid assembly transfer, a new laser marking tool, an automated solder ball shear inspection test, and the removal of a pre-screening inspection.
D970003/S119 5/20/10	Nexus I Entra SSIR, Nexus I Entra SSI, Nexus I Entra DDD, Nexus I Entra DDDR, Nexus I Plus DDDR, Discovery II SR, Insignia I Entra SSI, Insignia I Entra DDD, Insignia I Entra DDDR, Insignia I Entra SSIR, Insignia I Ultra DDDR, Insignia I Plus DDDR, Intelis II DR, and Intelis II SR	Boston Scientific Corporation St. Paul, MN 55112	Elimination of the outer sleeve wash step.
P970004/S085 5/20/10	Interstim iCOn Patient Programmer	Medtronic Neuromodulation Minneapolis, MN 55432	Addition of the supplemental Automated Optical Inspection (AOI).
P970027/S008 5/13/10	AxSYM Anti-HCV	Abbott Laboratories Diagnostic Division Abbott Park North, IL 60064	Change to the efficacy testing performed on new incoming lots of conjugate concentrate for the device.
P970031/S029 5/28/10	Freestyle® Aortic Root Bioprosthesis	Medtronic, Inc. Santa Ana, CA 92705	Addition of Gorditos Meats as an alternate supplier.
P980016/S236 5/12/10	EnTrust ICD, Virtuoso ICD, Intrinsic, Marquis, Maximo, Maximo II DR/VR, Virtuoso II DR/VR, Secura DR ICD, Secura VR ICD	Medtronic, Inc. Mounds View, MN 55112	Additional supplier for the plating process.
P980023/S040 5/13/10	Linox SD and Linox S Family of ICD Pacing Leads	Biotronik, Inc. Lake Oswego, OR 97035	Change in packaging to the inner and outer bags of the sterilized stylet accessories.
P980035/S165 5/12/10	EnRhythm IPG	Medtronic, Inc. Mounds View, MN 55112	Additional supplier for the plating process.
P980040/S033 5/20/10	TECNIS® Multifocal One-Piece Intraocular Lens	Advanced Medical Optics, Inc. Santa Ana, CA 92705	Change in the sterilization cycle parameters for the device.
P980043/S025 5/13/10	Hancock® II Bioprosthesis	Medtronic, Inc. Santa Ana, CA 92705	Change to the valve holder assembly process and inspection documents.
P980043/S026 5/28/10	Hancock® II Porcine Bioprosthesis	Medtronic, Inc. Santa Ana, CA 92705	Addition of Gorditos Meats as an alternate supplier.
P980049/S056 5/26/10	Paradym Family of ICDs	ELA Medical, Inc. Plymouth, MN 55441	Change in location of the hybrid electronic module subcomponent manufacturing.
P990001/S066 5/12/10	DA+ C-Series, DA+ T-Series	Medtronic, Inc. Mounds View, MN 55112	Additional supplier for the plating process.
P990037/S030 5/7/10	Vascular Solutions Duett Sealing Device	Vascular Solutions Minneapolis, MN 55369	Change in the quality control device used to monitor the sterilization process from an in-house manufactured sterilization process control device (SPCD) to a commercially purchased PCD.
P990064/S032 5/13/10	Mosaic® Porcine Bioprosthesis	Medtronic, Inc. Sana Ana, CA 92705	Change to the valve holder assembly process and inspection documents.
P990064/S033 5/28/10	Mosaic® Porcine Bioprosthesis	Medtronic, Inc. Santa Ana, CA 92705	Addition of Gorditos Meats as an alternate supplier.
P990066/S036 5/27/10	Senographe Digital Mammography System	GE Healthcare Waukesha, WI 53188	Change in supplier and replacement of obsolete computer systems.
P000006/S019 5/6/10	Titan Inflatable Penile Prosthesis	Coloplast Corp. Minneapolis, MN 55411	Use of an automated piece of equipment in dipping large size Titan cylinders.
P000039/S036 5/28/10	Amplatzer® Septal Occluder	AGA Medical Corporation Plymouth, MN 55442	Change in the supplier of the stitching yarn used in select Nitinol occlusion devices.
P010012/S234 5/20/10	Cognis, Contak Renewal, Contak Renewal 3 RF, Contak Renewal 3 HE, Contak Renewal 3 RF HE, Contak Renewal 3, Contak Renewal 3 AVT HE, Contak Renewal 4 AVT, Contak Renewal 4 AVT HE, Livian LV1 SE, and Livian LV1 HE	Boston Scientific Corporation St. Paul, MN 55112	Elimination of the outer sleeve wash step.
P010012/S240 5/19/10	Livian, Renewal 3, Renewal 3RF, and Renewal 3 AVT Families of Pulse Generators	Boston Scientific Corporation Cardiac Rhythm Management St. Paul, MN 55112	Plating change to the reed switch component.
P010012/S241 5/19/10	Contak Renewal, Contak Renewal 3, Contak Renewal 3 HE, Contak Renewal 3 RF, Contak Renewal 3 RF HE, Livian SE, and Livian HE Families of CRT-Ds	Boston Scientific Corporation Cardiac Rhythm Management St. Paul, MN 55112	Multiple cleaning and component testing changes for the crystal oscillator component.
P010012/S242 5/20/10	Contak Renewal 3 and Livian Families of CRT-Ds	Boston Scientific Corporation Cardiac Rhythm Management St. Paul, MN 55112	Changes in the suppliers for thin-film resistors.
P010021/S018 5/20/10	Vitros Immunodiagnostics Products Anti-HCV Reagent Pack and Calibrator	Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626	Addition of a new supplier of a raw material used in the manufacture of the Vitro Anti-HCV Calibrator.
P010031/S195 5/12/10	Concerto CRT-D, InSync II Marquis, Consulta CRT-D, InSync II Protect, InSync III Marquis, InSync Marquis, InSync II Protect, Maximo II CRT-D	Medtronic, Inc. Mounds View, MN 55112	Additional supplier for the plating process.
P010047/S003 5/25/10	Neomend ProGel™ Pleural Air Leak Sealant	NeoMend, Inc. Irvine, CA 92618	Modification of a test procedure used to determine the percent protein of human serum albumin in the component manufacturing process and for final release.
P020009/S063 5/13/10	Express 2® Coronary Stent System	Boston Scientific Corporation Cardiovascular Maple Grove, MN 55311	Change to the software used during a step in the stent manufacturing process.
P020024/S029 5/28/10	Amplatzer® Duct Occluder	AGA Medical Corporation Plymouth, MN 55442	Change in the supplier of the stitching yarn used in select Nitinol occlusion devices.
P020047/S019 5/21/10	Multi-Link Vision® OTW Coronary Stent System and Multi-Link Mini Vision® OTW Coronary Stent System	Abbott Vascular Temecula, CA 92591	Change to the extrusion manufacturing process.
P030005/S062 5/21/10	Contak Renewal TR	Boston Scientific Corporation St. Paul, MN 55112	Change in test limits.
P030005/S063 5/19/10	Contak Renewal TR Family of CRT-Ps	Boston Scientific Corporation Cardiac Rhythm Management St. Paul, MN 55112	Multiple cleaning and component testing changes for the crystal oscillator component.
P030005/S064 5/20/10	Contak Renewal TR	Boston Scientific Corporation St. Paul, MN 55112	Elimination of the outer sleeve wash step.
P030009/S041 5/13/10	Driver & Microdriver Coronary Stent Systems	Medtronic Vascular Santa Rosa, CA 95403	Addition of process equipment.
P030025/S088 5/13/10	TAXUS® Express 2® Paclitaxel-Eluting Coronary Stent System	Boston Scientific Corporation Cardiovascular Maple Grove, MN 55311	Replacement of the final inspection camera with one that performs the existing catheter Final Inspection process at the SDS Final Inspection station.
P030025/S089 5/13/10	TAXUS® Express 2® Paclitaxel-Eluting Coronary Stent System	Boston Scientific Corporation Cardiovascular Maple Grove, MN 55311	Changes to process software.
P030025/S090 5/13/10	TAXUS® Express 2® Paclitaxel-Eluting Coronary Stent System	Boston Scientific Corporation Cardiovascular Maple Grove, MN 55311	Change to the software used during a step in the stent manufacturing process.
P030031/S029 5/27/10	Navistar RMT Thermocool Catheter	Biosense Webster, Inc. Diamond Bar, CA 91765	Addition of second source supplier of the Pebax 40D Tubing.
P040002/S028 5/13/10	Powerlink® Stent Graft with IntuiTrak Delivery System	Endologix, Inc. Irvine, CA 92618	Change to the hemostasis handle assembly of the device.
P040016/S056 5/13/10	VeriFLEX® Coronary Stent System	Boston Scientific Corporation Cardiovascular Maple Grove, MN 55311	Change to the software used during a step in the stent manufacturing process.
P040016/S057 5/13/10	VeriFLEX (Liberté®) Coronary Stent System	Boston Scientific Corporation Cardiovascular Maple Grove, MN 55311	Change from a manual in-process inspection to an automated in-process inspection.
P040036/S022 5/27/10	Celsius RMT Thermocool Catheter	Biosense Webster, Inc. Diamond Bar, CA 91765	Addition of second source supplier of the Pebax 40D Tubing.
P040040/S013 5/28/10	Amplatzer® Muscular VSD Occluder	AGA Medical Corporation Plymouth, MN 55442	Change in the supplier of the stitching yarn used in select Nitinol occlusion devices.
P040044/S031 5/4/10	Mynx Vascular Closure Device	Access Closure, Inc. Mountain View, CA 04043	Change to a component joining process.
P050007/S025 5/21/10	StarClose SE® Vascular Closure System	Abbott Vascular, Inc Redwood City, CA 94063	Addition of a post-cure process to the manufacturing of the Release Rod component.
P050010/S005 5/26/10	ProDisc-L Total Disc Replacement	Synthes Spine West Chester, PA 19380	New Mahr perthometer that uses a different software version than the existing Mahr perthometer used to measure surface toughness.
P050010/S006 5/26/10	ProDisc-L Total Disc Replacement	Synthes Spine West Chester, PA 19380	Upgrade of the Rofin Baasel Software, which controls the etching machine, from version 1.0.54 to 1.0.61.
P050023/S030 5/13/10	Lumax Family of ICDs and CRT-Ds	Biotronik, Inc. Lake Oswego, OR 97035	Change in packaging to the inner and outer bags of the sterilized stylet accessories.
P060006/S012 5/13/10	Express® SD Renal Monorail® Premounted Stent System	Boston Scientific Corporation Cardiovascular Maple Grove, MN 55311	Change to the software used during a step in the stent manufacturing process.
P060008/S049 5/13/10	TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System	Boston Scientific Corporation Cardiovascular Maple Grove, MN 55311	Replacement of the final inspection camera with one that performs the existing catheter Final Inspection process at the SDS Final Inspection station.
P060008/S050 5/13/10	TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System	Boston Scientific Corporation Cardiovascular Maple Grove, MN 55311	Changes to process software.
P060008/S051 5/13/10	TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System	Boston Scientific Corporation Cardiovascular Maple Grove, MN 55311	Change to the software used during a step in the stent manufacturing process.
P060008/S052 5/13/10	TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System	Boston Scientific Corporation Cardiovascular Maple Grove, MN 55311	Change from a manual in-process inspection to an automated in-process inspection.
P060022/S007 5/19/10	Akreos® Posterior Chamber Intraocular Lens	Bausch & Lomb, Inc. Aliso Viejo, CA 92656	Elimination of the Ophthalmic Irrigation Solution Specification of the lens storage solution.
P060027/S023 5/26/10	Paradym Family of CRT-Ds	ELA Medical, Inc. Plymouth, MN 55441	Change in location of the hybrid electronic module subcomponent manufacturing.
P070015/S034 5/14/10	XIENCE V® and PROMUS™ Everolimus Eluting Coronary Stent Systems	Abbott Vascular Temecula, CA 92591	Change to the balloon manufacturing process.
P070015/S035 5/21/10	Promus™ OTW Everolimus-Eluting Coronary Stent System and Xience V® OTW Everolimus-Eluting Coronary Stent System	Abbott Vascular Temecula, CA 92591	Change to the extrusion manufacturing process.
P090003/S001 5/13/10	Express® LD Iliac Premounted Stent System	Boston Scientific Corporation Cardiovascular Maple Grove, MN 55311	Change to the software used during a step in the stent manufacturing process.

Summary of PMA Originals & Supplements Approved
Originals: 1
Supplements: 65

Summary of PMA Originals Under Review
Total Under Review: 82
Total Active: 34
Total On Hold: 48
Number Greater Than 180 Days: 6

Summary of PMA Supplements Under Review
Total Under Review: 591
Total Active: 386
Total On Hold: 205
Number Greater Than 180 Days: 17

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

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 65
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 144.7
FDA Time: 91.4 Days MFR Time: 53.3 Days

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