Some of the documents on this section of the CDRH Website are available only in PDF format and may not be accessible to those with certain disabilities. If you cannot access the documents you are interested in, please use the accessibility link for assistance. 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. Information about the PDF Reader is available.
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11/1/05 |
STAN® S31 Fetal Heart Monitor |
Neoventa Medial AB Molndal, Sweden SE-431 35 |
Approval for the STAN S31 Fetal Heart Monitor. The device is indicated as an adjunct to fetal heart rate monitoring to determine whether obstetrical intervention is warranted when there is increased risk of developing metabolic acidosis. The device is intended for use in patients with: 1) planned vaginal delivery; 2) >36 completed weeks gestation; 3) singleton fetus; 4) vertex presentation; and 5) ruptured amniotic membranes. |
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11/21/05 |
X STOP® Interspinous Process Decompression System |
St. Francis Medical Technologies, Inc. Alameda , CA 94501 |
Approval for the X STOP® Interspinous Process Decompression System. The device is indicated for treatment of patients aged 50 or older suffering from neurogenic intermittent claudication secondary to a confirmed diagnosis of lumbar spinal stenosis (with X-Ray, MRI, and /or CT evidence of thickened ligamentum flavum, narrowed lateral recess and/or central canal narrowing). The X STOP® is indicated for those patients with moderately impaired physical function who experience relief in flexion from their symptoms of leg/buttock/groin pain, with or without back pain, and have undergone a regimen of at least 6 months of nonoperative treatment. The X STOP may be implanted at one or two lumbar levels in patients in whom operative treatment is indicated at no more than two levels. |
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11/18/05 |
GEM 21S (Growth-factor Enhanced Matrix) |
Biomimetic Pharmaceuticals, Inc. Franklin , TN 37067 |
Approval for the GEM 21S (Growth-factor Enhanced Matrix). The device is indicated to treat the following periodontally related defects: 1) Intrabony periodontal defects 2) Furcation periodontal defects 3) Gingival recession associated with periodontal defects. |
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11/18/05 |
Therapy™ Dual 8™ Cardiac Ablation System |
Irvine Biomedical, Inc. Irvine , CA 92614 |
Approval for the Therapy Dual 8 Cardiac Ablation System. The device is indicated for the treatment of typical atrial flutter. |
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11/10/05 |
Coaptite® |
Bioform Medical, Inc. San Mateo , CA 94402 |
Approval for Coaptite®. The device is indicated for soft tissue augmentation in the treatment of stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) in adult females. |
P810046/S217 11/22/05 180-Day |
RX Voyager™ Coronary Dilatation Catheter |
Guidant Corporation Temecula , CA 92591 |
Approval for a manufacturing site located at Guidant Ireland, Tippery, Ireland . |
P830055/S092 11/17/05 Special |
LCS® Total Knee System – PFC Sigma RPF Knee System |
DePuy Orthopaedics, Inc. Warsaw , IN 46581 |
Approval for changes in quality controls to the femoral components of the above referenced components. These modifications add a requirement for line clearance and a step for color code sticker verification by a second operator to Manufacturing Process Specification (MPS) – 1699. The 2 nd operator color code sticker verification step is also being added to the Travelers for the affected product. |
P840001/S082 11/4/05 Real-Time |
Synergy®, Synergy Versitrel®, Synergy Plus+™, and Synergy Compact Plus+™ |
Medtronic, Inc. Minneapolis , MN 55432 |
Approval for the Model 3776 1x8 SC (Subcompact) Low Impedance Lead Kit and the Model 3876 1X8 SC Low Impedance Lead Kit. |
P860004/S074 11/3/05 135-Day |
Medtronic Synchromed® II Programmable Drug Infusion Pump |
Medtronic, Inc. Minneapolis , MN 55432 |
Approval for addition of Nusil 1137 silicone adhesive to the catheter fitting o-ring assembly. |
P860004/S077 11/22/05 Real-Time |
Medtronic Synchromed® II Implantable Programmable Drug Infusion System |
Medtronic, Inc. Minneapolis , MN 55432 |
Approval for the following modifications: 1) change the composition of the motor coil pin connector material from a phosphor bronze containing some lead to a lead-free phosphor bronze; and 2) modify the weld coating process from one large mound of silicone varnish over both motor coil connector pins to individual mounds over each pin. |
P890003/S091 11/15/05 Real-Time |
Medtronic Model 2490G CareLink Monitor, Model 2020A CardioSight Reader and Model 2491 DDMA Software to support the EnTrust ICDs |
Medtronic, Inc. Minneapolis , MN 55432 |
Approval for 1) Medtronic Model 2490G CareLink Monitor, Model 2020A CardioSight Reader and Model 2491 DDMA Software to support the EnTrust ICDs 2) To make OptiVol information without the threshold line available for InSync Sentry Models 7297 and 7299 viewable by physicians using the CareLink Network. |
P890003/S095 11/22/05 Real-Time |
Medtronic Reveal Plus Insertable Loop Recorder (ILR) Application Software Model 9809 |
Medtronic, Inc. Minneapolis , MN 55432 |
Approval for a software update, software series 5.0 to software series 6.0, to correct a minor customer inconvenience anomaly with telemetry error conditions related to the retry strategy by addition of an enhancement check to ensure that all of the event data has been received. |
P900060/S034 11/30/05 135-Day |
Carbomedics Prosthetic Heart Valve (CPHV), Carbo-Seal Ascending Aortic Prosthesis (AAP) and Carbo-Seal Valsalva™ Ascending Aortic Prosthesis (AAP) |
Carbomedics, Inc. Austin , TX 78752 |
Approval to substitute an outside vendor for specific metal components of the prosthetic heart valves. The devices, as modified, will be marketed under the trade names Carbomedics prosthetic Heart Valve (CPHV), Carbo-Seal Ascending Aortic Prosthesis (AAP) and Carbo-Seal Valsalva Ascending Aortic Prosthesis (AAP). |
P910023/S085 11/28/05 Real-Time |
Modifications to the Septum Design of all St. Jude Medical ICDs (VR and DR Models) |
St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Approval for modifications to the septum design of all St. Jude Medical ICDs(VR and DR Models.) |
P910065/S006 11/30/05 180-Day |
AIA-PACK PA PSA, ST AIA-PACK PA PSA |
TOSOH Bioscience, Inc. South San Francisco , CA 94080 |
Approval for changes in the manufacturing process of the monoclonal antibodies used in the production of the assays and change in the manufacturing facility used for the above manufacturing process from Nisseiken Co., Ltd., Tokyo , Japan to TOSOH AIA, Inc. in Toyama , Japan . |
P910073/S055 11/15/05 Real-Time |
ENDOTAK RELIANCE AND ENDOTAK ENDURANCE |
Guidant Corporation St. Paul , MN 55112 |
Approval to extend the shelf life of the drug plug component of the leads from one year to three years. The shelf life of the finished leads remains two years. |
P950001/S015 11/15/05 Real-Time |
SELUTE AND SELUTE PICOTIP |
Guidant Corporation St. Paul , MN 55112 |
Approval to extend the shelf life of the drug plug component of the leads from one year to three years. The shelf life of the finished leads remains two years. |
P950022/S025 11/4/05 180-Day |
St. Jude Medical Riata™ and Riata™ i Defibrillation Lead Models 1940, 1941, 1942, 1950, 1051, 1962 |
St. Jude Medical CRMD Sunnyvale , CA 94086 |
Approval for the addition of six lead models with Elast-Eon™ 2A lead body insulation material to the St. Jude Medical Riata/Riata i Defibrillation Lead System. |
P960040/S075 11/24/05 135-Day |
PRIZM family |
Guidant Corporation St. Paul , MN 55112 |
Approval for the use of four new Inner Lead Bonding (ILB) machines on the Tape Automated Bonding (TAB) manufacturing line for pulse generators. |
P960040/S086 11/10/05 Real-Time |
Vitality Family of AICDs and Prizm 1 Family of AICDs |
Guidant CRM St. Paul , MN 55112 |
Approval to replace the existing polyimide tubing that provides insulation in the pulse generator header assembly with polyetheretherke-tone (PEEK) tubing. |
D970003/S045 11/24/05 135-Day |
DISCOVERY/ PULSAR MAX/ INSIGNIA/ NEXUS/INTELIS family |
Guidant Corporation St. Paul , MN 55112 |
Approval for the use of four new Inner Lead Bonding (ILB) machines on the Tape Automated Bonding (TAB) manufacturing line for pulse generators. |
P970003/S059 11/8/05 180-Day |
VNS Therapy System |
Cyberonics, Inc. Houston , TX 77058 |
Approval of the post-approval study protocol. |
P970003/S060 11/8/05 180-Day |
VNS Therapy System |
Cyberonics, Inc. Houston , TX 77058 |
Approval of the post-approval study protocol. |
P980016/S055 11/15/05 Real-Time |
Medtronic Model 9996 and Model 9997 Application Software Version 2.0 used with Intrinsic 30 Model 7287 and Intrinsic Model 7288 ICD Systems |
Medtronic, Inc. Minneapolis , MN 55432 |
Approval for Medtronic Model 9996 and Model 9997 Application Software version 2.0 used with Intrinsic 30 Model 7287 and Intrinsic Model 7288 ICD System. |
P980016/S058 11/15/05 Real-Time |
Medtronic Model 2490G CareLink Monitor, Model 2020A CardioSight Reader and Model 2491 DDMA Software to support the EnTrust ICDs |
Medtronic, Inc. Minneapolis , MN 55432 |
Approval for 1) Medtronic Model 2490G CareLink Monitor, Model 2020A CardioSight Reader and Model 2491 DDMA Software to support the EnTrust ICDs 2) To make OptiVol information without the threshold line available for InSync Sentry Models 7297 and 7299 viewable by physicians using the CareLink Network. |
P990001/S020 11/22/05 Real-Time |
Vitatron C60 DR Model C60A1, Vitatron C20 SR Model C20A1, Vitatron C60 DR Model C60A3, Vitatron C20 SR Model C20A3, Vitatron T60 DR Model T60A1 and Vitatron T20 SR Model T20A1 |
Vitatron Minneapolis , MN 55432 |
Approval for software revisions. |
P990012/S003 11/9/05 Special |
Elecsys HBsAg Test System |
Roche Diagnostics Operations, Inc. Indianapolis , IN 46250 |
Approval for the addition of in-process testing. |
P990052/S011 11/23/05 180-Day |
Vibrant® Soundbridge® Implantable Middle Ear Hearing Device (IMEHD) |
MED-EL Medical Electronic GmbH Innsbruck , Austria A-6020 |
Approval for a manufacturing site located at MED-EL Medical Electronics, Innsbruck , Austria . |
P010012/S066 11/24/05 135-Day |
CONTAK RENEWAL family |
Guidant Corporation St. Paul , MN 55112 |
Approval for the use of four new Inner Lead Bonding (ILB) machines on the Tape Automated Bonding (TAB) manufacturing line for pulse generators. |
P010012/S076 11/10/05 Real-Time |
Contak Renewal 1 |
Guidant CRM St. Paul , MN 55112 |
Approval to replace the existing polyimide tubing that provides insulation in the pulse generator header assembly with polyetheretherke-tone (PEEK) tubing. |
P010031/S028 11/15/05 Real-Time |
Medtronic Model 2490G CareLink Monitor, Model 2020A CardioSight Reader and Model 2491 DDMA Software to support the EnTrust ICDs |
Medtronic, Inc. Minneapolis , MN 55432 |
Approval for 1) Medtronic Model 2490G CareLink Monitor, Model 2020A CardioSight Reader and Model 2491 DDMA Software to support the EnTrust ICDs 2) To make OptiVol information without the threshold line available for InSync Sentry Models 7297 and 7299 viewable by physicians using the CareLink Network. |
P010032/S017 11/16/05 180-Day |
Genesis, Genesis RC and the Eon Neurostimulation Systems |
Advanced Neuromodulation Systems |
Approval for the Rapid Programmer, Models 3830 and 3831, which are indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain. |
P010051/S003 11/2/05 Special |
IMMULITE®/ IMMULITE® 1000 and IMMULITE® 2000 Anti-HBc |
Diagnostic Products Corporation Los Angeles , CA 90045 |
Approval for changes in the manufacturing process which add an incoming raw material test. |
P010052/S003 11/2/05 Special |
IMMULITE®/ IMMULITE® 1000 and IMMULITE® 2000 Anti-HBs |
Diagnostic Products Corporation Los Angeles , CA 90045 |
Approval for changes in the manufacturing process which add an incoming raw material test. |
P010053/S003 11/2/05 Special |
IMMULITE®/ IMMULITE® 1000 and IMMULITE® 2000 Anti-HBc IgM |
Diagnostic Products Corporation Los Angeles , CA 90045 |
Approval for changes in the manufacturing process which add an incoming raw material test. |
P020045/S011 11/18/05 Special |
7F Freezor Cardiac CryoAblation Catheter & CCT.2 CryoConsole System |
CryoCath Technologies, Inc. Kirkland , Quebeck , Canada H9H 5H3 |
Approval for changes in internal quality inspection and controls process to add new fit test methods to specified incoming components. |
P020045/S012 11/18/05 Special |
7F Freezor Cardiac CryoAblation Catheter & CCT.2 CryoConsole System |
CryoCath Technologies, Inc. Kirkland , Quebeck , Canada H9H 5H3 |
Approval for changes in both the incoming and final quality inspections from the current method of a random sampling of devices to evaluating 100% of the incoming shafts coil dimensions and performing deflection testing on 100% of the finished shafts. |
P030017/S010 11/17/05 Real-Time |
PRECISION™ Spinal Cord Stimulation (SCS) System |
Advanced Bionics Sylmar , CA 91342 |
Approval for the Detachable Charger Pouch, Model SC-6356. |
P030022/S001 11/17/05 Real-Time |
Reflection® Ceramic Acetabular System |
Smith & Nephew, Inc. Memphis , TN 38116 |
Approval for the addition of the ANTHOLOGY Hip Stem for use with the previously approved Reflection® Ceramic Acetabular System. The device is indicated for use in patients requiring primary total hip arthroplasty due to non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, avascular necrosis, or traumatic arthritis. |
P030032/S004 11/2/05 Real-Time |
Hylaform and Hylaform Plus |
Genzyme Corporation Cambridge , MA 02142 |
Approval for an extension of the Hylaform and Hylaform Plus shelf life from 24 to 36 months. |
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11/18/05 Panel |
Epic™ and Atlas®+ HF CRT-D Systems |
St. Jude Medical CRMD Sunnyvale , CA 94086 |
Approval for the modification of the indications for the Epic ™ and Atlas ®+ HF CRT-D Systems, specifically the maintenance of synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic (permanent) atrial fibrillation and have NYHA Class II or III heart failure. The St. Jude Medical the Epic ™ and Atlas ®+ HF CRT-D Systems are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. In patients indicated for an ICD, the Epic ™ and Atlas ®+ HF CRT-D Systems are also intended: 1) to provide a reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy (as defined in the clinical trials section) and have a left ventricular ejection fraction less than or equal to 35% and a prolonged QRS duration 2) to maintain synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic (permanent) atrial fibrillation and have NYHA Class II or III heart failure. |
P030054/S014 11/28/05 Real-Time |
Modification to the Septum Design of all St. Jude Medical ICDs and CRT-Ds |
St. Jude Medical CRMD Sylmar , CA 91342 |
Approval for modifications to the septum design of all St. Jude Medical ICDs and CRT-Ds. |
P030054/S015 11/15/05 Real-Time |
Merlin™ Patient Care System for use with the Affinity/Integrity, Photon and Atlas+, Epic and PSA Pulse Generators, Model 3330 Version 1.1 Software, Model 3616 Wand Extension Cable, and Model 3617 ECG input cable |
St. Jude Medical CRMD Sylmar , CA 91342 |
Approval for the Model 3650 Merlin™ Patient Care System with the Model 3330 Version 1.1 Software, Model 3616 Wand extension Cable, and Model 3617 ECG input cable. |
30-Day Notices (135 Day Supplement was not required)
P840001/S086 11/30/05 |
Implantable Neurostimulators |
Medtronic, Inc. Minneapolis , MN 55432 |
Change in the Ethylene Oxide exposure time. |
P910023/S084 11/2/05 |
Implantable Cardioverter Defibrillator and Cardiac Resynchronization Therapy Devices (ICD and CRT-Ds) |
St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Alternate manufacturing process change to allow component curing in an autoclave system, with subsequent reduction in process time. |
P910023/S087 11/18/05 |
Photon, Epic, and Atlas families of Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) |
St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Change from manual epoxy dispensing method to an automated robot controlled epoxy dispensing system. |
P910073/S057 11/22/05 |
RELIANCE ACTIVE FIX and PASSIVE FIX Steroid Eluting Endocardial Defibrillation Lead |
Guidant Corporation St. Paul , MN 55112 |
Addition of sight holes to the terminal pins, with increase in insertion cavity for the passive fix version, resulting in an additional inspection step. |
P910073/S058 11/23/05 |
RELIANCE Implantable Cardioverter Defibrillator Leads |
Guidant Corporation St. Paul , MN 55112 |
Change of silicone adhesive. |
P960009/S034 11/30/05 |
Implantable Neurostimulators |
Medtronic, Inc. Minneapolis , MN 55432 |
Change in the Ethylene Oxide exposure time. |
D970003/S052 11/30/05 |
INSIGNIA and NEXUS |
Guidant Corporation St. Paul , MN 55112 |
Transfer of the assembly and testing functions of the filtered feedthrough manufacturing process to a second supplier location. |
P970004/S036 11/8/05 |
InterStim® Implantable Neurostimulator |
Medtronic Gastroenterology and Urology Shoreview , MN 55126 |
Change in time for the sterilization cycle. |
P980031/S009 11/23/05 |
INTACS® Prescription Inserts |
Addition Technology, Inc. Sunnyvale , CA 94089 |
Transfer of non-critical “As/Manufactured” dimensional inspections of width, symmetry, outer diameter, arc length, and drill hole placement for machined INTACS Prescription Inserts from Biotest Laboratories to Ocular Technology Inc. |
P000044/S009 11/17/05 |
VITROS Immunodiagnostic Products HBsAg Reagent Pack and Calibrators |
Ortho-Clinical Diagnostics, Inc. Rochester , NY 14626 |
Addition of an alternative supplier for anti-HBs antibody used in the manufacture of the VITROS HBsAg Reagent Pack and Calibrators. |
P010012/S079 11/23/05 |
RENEWAL 3 RF CRT-D, Models H210, H215, H217 and H219 |
Guidant Corporation St. Paul , MN 55112 |
Removal of ZOOM E3 Test from the build process. |
P020004/S014 11/30/05 |
Gore EXCLUDER® Bifurcated Endoprosthesis |
W.L. Gore & Associates Flagstaff , AZ 86003 |
Elimination of a redundant stent wire cleaning step. |
P020024/S009 11/30/05 |
AMPLATZER® Duct Occluder |
AGA Medical Corporation Golden Valley , MN 55427 |
Addition of a nitinol wire brain heat treatment step to the manufacturing process. |
P030005/S023 11/30/05 |
CONTAK RENEWAL TR |
Guidant Corporation St. Paul , MN 55112 |
Transfer of the assembly and testing functions of the filtered feedthrough manufacturing process to a second supplier location. |
P030025/S025 11/10/05 |
TAXUS Express2™ Paclitaxel-Eluting Coronary Stent System |
Boston Scientific Corporation Maple Grove , MN 55311 |
Change in the supplier and model number of the incubator/shaker apparatus that is used in the drug assay of the device. |
P030054/S013 11/2/05 |
Implantable Cardioverter Defibrillator and Cardiac Resynchronization Therapy Devices (ICD and CRT-Ds) |
St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Alternate manufacturing process change to allow component curing in an autoclave system, with subsequent reduction in process time. |
P030054/S017 11/18/05 |
Photon, Epic, and Atlas families of Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) |
St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Change from manual epoxy dispensing method to an automated robot controlled epoxy dispensing system. |
P040043/S007 11/30/05 |
Gore TAG Thoracic Endoprosthesis |
W.L. Gore & Associates Flagstaff , AZ 86003 |
Elimination of a redundant stent wire cleaning step. |
Summary of PMA Originals & Supplements Approved
Originals: 5
Supplements: 37
Summary of PMA Originals Under Review
Total Under Review: 91
Total Active: 39
Total On Hold: 52
Number Greater Than 180 Days: 2
Summary of PMA Supplements Under Review
Total Under Review: 374
Total Active: 177
Total On Hold: 197
Number Greater Than 180 Days: 8
Summary of All PMA Submissions Received
Originals: 5
Supplements: 92
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 37
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 89.8
FDA Time: 56.7 Days MFR Time: 33.1 Days
Updated April 26, 2006
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