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.
PMA Original Approvals
| P040040 9/7/07 |
The Amplatzer® Muscular VSD Occluder | AGA Medical Corporation Golden Valley, MN 55427 |
Approval for The Amplatzer® Muscular VSD Occluder. The device is indicated for use in patients with a complex ventricular septal defect (VSD) of significant size to warrant closure (large volume left to right shunt, pulmonary hypertension and/or clinical symptoms of congestive heart failure) who are considered to be at high risk for standard transatrial or transarterial surgical closure based on anatomical conditions and/or based on overall medical condition. High risk anatomical factors for transatrial or transarterial surgical closure include patients: 1) Requiring left ventriculotomy or an extensive right ventriculotomy; 2) With a failed previous VSD closure; 3) With multiple apical and/or anterior muscular VSDs (“Swiss Cheese Septum”); or 4) With posterior apical VSDs covered by trabeculae. |
| P070009 9/28/07 |
REALIZE™ Adjustable Gastric Band Model 2200-X | Obtech Medical GMBH Zug, Switzerland 6300 |
Approval for the REALIZE ™ Adjustable Gastric Band. This device is indicated for weight reduction for morbidly obese patients and is indicated for individuals with a Body Mass Index (BMI) of at least 40 kg/m 2, or a BMI of at least 35 kg/m 2 with one or more comorbid conditions. The Band is indicated for use only in morbidly obese adult patients who have failed more conservative weight-reduction alternatives, such as supervised diet, exercise and behavior modification programs. |
PMA Supplemental Approvals
| P810046/S222 9/27/07 |
VOYAGER™ OTW Coronary Dilatation Catheter | Abbott Vascular, Inc. Temecula, CA 92591 |
Approval for an addition of a lubricious coating to the inner lumen of the catheter. |
| P820003/S081 9/28/07 Real-Time |
Medtronic Model 5348 and Model 5388 External Pulse Generators | Medtronic, Inc. Cardiac Rhythm Disease Management Shoreview, MN 55126 |
Approval for minor design changes and internal component updates to Medtronic Model 5348 and Model 5388 External Pulse Generators. |
| P850048/S022 9/18/07 180-Day |
ACCESS® (Hybritech®) PSA Reagents on the ACCESS® Immunoassay Systems | Beckman Coulter, Inc. Chaska, MN 55318 |
Approval for the use of the ACCESS® (Hybritech®) PSA reagents on the UniCel® DxI 600 ACCESS® Immunoassay System. |
| P890003/S114 9/14/07 180-Day |
CareLink Monitor Models 2490G, 2490H, 2490J, and the 2020A CardioSight Reader | Medtronic, Inc. Minneapolis, MN 55432 |
Approval for a manufacturing site located at Plexus Services Corp., Penang, Malaysia. |
| P890003/S124 9/18/07 Real-Time |
Thera/Prodigy | Medtronic, Inc. Shoreview, MN 55126 |
Approval for a change to the XM485 and XM486 wire bond terminal blocks found in Medtronic Kappa 700, Kappa 900, EnPulse, Adapta/Versa/ Sensia, Sigma, 350 Series, Thera/Prodigy, Kappa 400, and InSync-II Implantable Pulse Generator and Cardiac Resynchronization Therapy Pacemaker (CRT-P) Families. |
| P890003/S126 9/11/07 Special |
Model 2490G/H/J Medtronic CareLink Monitor and the Model 2020A CardioSight Reader | Medtronic, Inc. Shoreview, MN 55126 |
Approval for labeling changes that add an instruction that is intended to enhance the safe use of the device. |
| P890055/S021 9/7/07 180-Day |
GEM Model 7227 Implantable Device | Codman Raynham, MA 02767 |
Approval for a sterilization site located at Steris-Isomedix, Northborough, Massachusetts. |
| P900061/S071 9/14/07 180-Day |
CareLink Monitor Models 2490G, 2490H, 2490J, and the 2020A CardioSight Reader | Medtronic, Inc. Minneapolis, MN 55432 |
Approval for a manufacturing site located at Plexus Services Corp., Penang, Malaysia. |
| P900061/S073 9/11/07 Special |
Model 2490G/H/J Medtronic CareLink Monitor and the Model 2020A CardioSight Reader | Medtronic, Inc. Shoreview, MN 55126 |
Approval for labeling changes that add an instruction that is intended to enhance the safe use of the device. |
| P910023/S132 9/11/07 180-Day |
Promote Models 3207-36 and 3207-30 |
St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Approval for adding the wireless communication between the programmer and the implantable devices. |
| P910071/S009 9/12/07 135-Day |
ADATO® SIL-OL 5000 Silicone Oil | Bausch & Lomb, Inc. San Dimas, CA 91773 |
Approval to change molding technology. |
| P930014/S020 9/6/07 135-Day |
AcrySof® Single-Piece Intraocular Lens (IOL) | Alcon Research Ltd. Fort Worth, TX 76134 |
Approval to add a vision enhancement system to the automill in the manufacturing of the intraocular lenses. |
| P950022/S040 9/6/07 Real-Time |
Riata STS Optim Lead Models 7120, 7121, 7122, 7130 and 7131 | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Approval for distal tip changes to the Riata ST Optim lead family. The device, as modified, will be marketed under the trade name Riata STS Optim Lead Models 7120, 7121, 7122, 7130 and 7131, and are indicated for use as transvenous, steroid eluting, right ventricular dual and single defibrillation coil leads with compatible pulse generators. |
| P950042/S004 9/5/07 180-Day |
PINPOINT™ Endoscopic Light Source and Video Camera | Novadaq Technologies, Inc. Mississauga, Ontario, Canada L4W rL5 |
Approval for a trade name change from Onco-LIFE™ to PINPOINT™ Endoscopic Light Source and Video Camera. |
| P960011/S011 9/13/07 Real-Time |
Biolon™ 1% Sodium Hyaluronate | Ferring Pharmaceuticals, Inc. Suffern, NY 10901 |
Approval for a change in inflammation testing for bulk sodium hyaluronate from oxidative burst testing to an IL-6 ELISA method. |
| P960016/S019 9/24/07 Real-Time |
Safire Cardiac Ablation System | St. Jude Medica Atrial Fibrillation Division Minnetonka, MN 55345 |
Approval for labeling modifications that allows: 1) the IBI-1500T6 and T9 Cardiac Ablation Generators (equipped with temperature monitoring) to be used with the Safire Bi-directional Ablation Catheter and 2) the extension cables (previously approved under P960016/S016 for use with the IBI-1500T6) be used with the IBI-1500 T9 RF Generator. |
| P960040/S143 9/19/07 135-Day |
PRIZM, PRIZM II Cardiac Resynchronization Therapy Defibrillators (CRT-D) | Guidant Corporation St. Paul, MN 55112 |
Approval for the addition of an alternate supplier for integrated circuit wafer gold bumping service for the PRIZM and PRIZM II CRT-D devices. |
| P960053/S004 9/28/07 180-Day |
SBI Braun-Cutter Trapez-Metacarpal Prosthesis | Small Bone Innovations Morrisville, PA 19067 |
Approval for a manufacturing site located at Professional Contract Sterilization, Taunton, Massachusetts. |
| P970012/S028 9/18/07 Real-Time |
Kappa 400 | Medtronic, Inc. Shoreview, MN 55126 |
Approval for a change to the XM485 and XM486 wire bond terminal blocks found in Medtronic Kappa 700, Kappa 900, EnPulse, Adapta/Versa/ Sensia, Sigma, 350 Series, Thera/Prodigy, Kappa 400, and InSync-II Implantable Pulse Generator and Cardiac Resynchronization Therapy Pacemaker (CRT-P) Families. |
| P970038/S009 9/19/07 180-Day |
ACCESS® (Hybritech®) Free PSA Reagents on the ACCESS® Immunoassay Systems | Beckman Coulter, Inc. Chaska, MN 55318 |
Approval for the use of the ACCESS® (Hybritech®) free PSA reagents on the UniCel® DxI 600 ACCESS® Immunoassay System. |
| P980016/S092 9/14/07 180-Day |
CareLink Monitor Models 2490G, 2490H, 2490J, and the 2020A CardioSight Reader | Medtronic, Inc. Minneapolis, MN 55432 |
Approval for a manufacturing site located at Plexus Services Corp., Penang, Malaysia. |
| P980016/S108 9/11/07 Special |
Gem DR, Gem II DR and VR, Gem III DR and VR, Onyx, Marquis DR and VR, Maximo DR and VR, Intrinsic and Intrinsic 30, Virtuoso, and EnTrust Family of Implantable Devices |
Medtronic, Inc. Shoreview, MN 55126 |
Approval for labeling changes that add an instruction that is intended to enhance the safe use of the device. |
| P980035/S069 9/14/07 180-Day |
CareLink Monitor Models 2490G, 2490H, 2490J, and the 2020A CardioSight Reader | Medtronic, Inc. Minneapolis, MN 55432 |
Approval for a manufacturing site located at Plexus Services Corp., Penang, Malaysia. |
| P980035/S075 9/18/07 Real-Time |
Kappa 700, Kappa 900, EnPulse, Adapta/Versa/ Sensia, Sigma, and Medtronic 350 Series | Medtronic, Inc. Shoreview, MN 55126 |
Approval for a change to the XM485 and XM486 wire bond terminal blocks found in Medtronic Kappa 700, Kappa 900, EnPulse, Adapta/Versa/ Sensia, Sigma, 350 Series, Thera/Prodigy, Kappa 400, and InSync-II Implantable Pulse Generator and Cardiac Resynchronization Therapy Pacemaker (CRT-P) Families. |
| P980035/S076 9/11/07 Special |
Kappa 600/700/800/900 and EnPulse, EnRhythm, Adapta, Versa and Sensia Pacemakers | Medtronic, Inc. Shoreview, MN 55126 |
Approval for labeling changes that add an instruction that is intended to enhance the safe use of the device. |
| P980041/S009 9/12/07 180-Day |
ACCESS® AFP Reagents on the ACCESS® Immunoassay Systems | Beckman Coulter, Inc. Chaska, MN 55318 |
Approval for the use of the ACCESS® AFP reagents on the UniCel® DxI 600 ACCESS® Immunoassay System. |
| P000021/S010 9/14/07 Real-Time |
Dimension® TPSA Flex® Reagent Cartridge | Dade Behring, Inc. Newark, DE 19714 |
Approval for the Dimension® TPSA Flex® Reagent Cartridge on the Dimension® EXL™ Clinical Chemistry System. |
| P000025/S023 9/24/07 180-Day |
COMBI 40+ Cochlear Implant System with MAESTRO System Software version 2.0.1 and Opus-1 Speech Processor | Med-El Corporation Durham, NC 27713 |
Approval for the OPUS-1 external speech processor and the MAESTRO 2.0.1, which are new components of the approved COMBI 40+ cochlear implant system and are indicated for use on patients who have been implanted with PULSAR CI 100 and/or SONATA TI 100 cochlear implants. The software, MAESTRO 2.0.1, is intended for programming the OPUS-1 speech processor, and implements two new speech coding strategy features, High Definition CIS (HDCIS) and Fine Structure Processing (FSP). |
| P000025/S027 9/25/07 Special |
COMBI 40+ Cochlear Implant System | Med-El Corporation Durham, NC 27713 |
Approval for changes to the Microphone Test Device (MTD) Users Manual. |
| P010014/S016 9/12/07 Special |
Oxford® Meniscal Unicompartmental Knee System | Biomet, Inc. Warsaw, IN 46581 |
Approval for new fixturing to be used during the manufacturing of the tibial components of the Oxford Meniscal Unicompartmental Knee System to prevent components being mis-marked. |
| P010015/S031 9/18/07 Real-Time |
InSync III | Medtronic, Inc. Shoreview, MN 55126 |
Approval for a change to the XM485 and XM486 wire bond terminal blocks found in Medtronic Kappa 700, Kappa 900, EnPulse, Adapta/Versa/ Sensia, Sigma, 350 Series, Thera/Prodigy, Kappa 400, and InSync-II Implantable Pulse Generator and Cardiac Resynchronization Therapy Pacemaker (CRT-P) Families. |
| P010031/S059 9/14/07 180-Day |
CareLink Monitor Models 2490G, 2490H, 2490J, and the 2020A CardioSight Reader | Medtronic, Inc. Minneapolis, MN 55432 |
Approval for a manufacturing site located at Plexus Services Corp., Penang, Malaysia. |
| P010031/S073 9/13/07 180-Day |
InSync ICD Model 7272 System | Medtronic, Inc. Shoreview, MN 55126 |
Approval for a labeling update to add a clinical summary for the completed InSync ICD Model 171 post-approval study. |
| P010031/S078 9/11/07 Special |
InSync IC, InSync Marquis, InSync Maximo, InSync Sentry, InSync II Marquis and InSync III Marquis and Concerto Implantable Devices | Medtronic, Inc. Shoreview, MN 55126 |
Approval for labeling changes that add an instruction that is intended to enhance the safe use of the device. |
| P020001/S002 9/26/07 Real-Time |
STAN S31 Fetal Heart Monitor | Neoventa Medical AB Washington, DC 20002 |
Approval for a change to the LCD panel model, power supply unit, and addition of an internal fan. The device is indicated for use 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. |
| P020004/S027 9/4/07 135-Day |
Gore EXCLUDER® AAA Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 86003 |
Approval for machine-assisted stent winding equipment as an alternate process in the manufacture of the device. |
| P020018/S022 9/25/07 135-Day |
Zenith AAA Endovascular Graft w/H&L One Shot Introduction System | Cook, Inc Bloomington, IN 47402 |
Approval for a change to the 304v stainless steel wire supplier’s process to include 100% eddy current testing. |
| P020027/S006 9/14/07 Real-Time |
Dimension® FPSA Flex® Reagent Cartridge | Dade Behring, Inc. Newark, DE 19714 |
Approval for the Dimension® FPSA Flex® Reagent Cartridge on the Dimension® EXL™ Clinical Chemistry System. |
| P020036/S008 9/20/07 Special |
S.M.A.R.T. Nitinol Stent System | Cordis Corporation Warren, NJ 07059 |
Approval for the establishment of an additional specification for a bismuth subcarbonate blend raw material. |
| P030047/S005 9/20/07 Special |
PRECISE Nitinol Stent System | Cordis Corporation Warren, NJ 07059 |
Approval for the establishment of an additional specification for a bismuth subcarbonate blend raw material. |
| P030054/S050 9/11/07 180-Day |
Current ICD Models 1207-36, 1207-30, 2207-36 and 2207-30 | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Approval for adding the wireless communication between the programmer and the implantable devices. |
| P040006/S004 9/5/07 180-Day |
CHARITÉ Artificial Disc | DePuy Spine, Inc. Raynham, MA 02767 |
Approval for: 1) additional endplates with larger footprint, lateral placement of fixation teeth, and 1 mm offset articulating surface; 2) additional cores with modified outer rim; 3) modified surgical instruments to accommodate modified device components; and 4) modified surgical technique. |
| P040020/S004 9/6/07 135-Day |
AcrySof® ReSTOR Apodized Diffractive Aspheric Intraocular Lens (IOL) | Alcon Research Ltd. Fort Worth, TX 76134 |
Approval to add a vision enhancement system to the automill in the manufacturing of the intraocular lenses. |
| P040023/S009 9/3/07 180-Day |
Duraloc® Option Ceramic Hip System | DePuy Orthopaedics, Inc. Warsaw, IN 46581 |
Approval of the post-approval study for the device. |
| P040044/S002 9/20/07 Special |
Mynx™ Vascular Closure Device | AccessClosure, Inc. Mountain View, CA 94043 |
Approval for additional warnings regarding device use at particular puncture site locations in the Instructions for Use (IFU) for the device. |
| P050006/S001 9/21/07 180-Day |
GORE HELEX™ Septal Occluder | W.L. Gore & Associates, Inc. Flagstaff, AZ 86003 |
Approval for design modifications for the catheter delivery system (HELIX 1.5 delivery system). |
| P060018/S001 9/18/07 Special |
PRESTIGE® Cervical Disc | Medtronic Sofamor Danek Memphis, TN 38132 |
Approval for changes to the surgical technique manual (i.e., modification of Figure 8 and the addition of a cautionary note). |
30-Day Notices (135 Day Supplement was not required)
| P810046/S223 9/19/07 |
VOYAGER™ Coronary Dilatation Catheter | Abbott Vascular, Inc. Temecula, CA 92591 |
Modification of the cutting process for necked tungsten tubing from a manual to an automated process. |
| P810046/S224 9/19/07 |
VOYAGER™ OTW Coronary Dilatation Catheter | Abbott Vascular, Inc. Temecula, CA 92591 |
Modification of the manufacturing tools and in-process parameters used during outer membrane necking and proximal balloon sealing. |
| P900033/S017 9/21/07 |
INTEGRA Dermal Regeneration Template | Integra Life Sciences Corporation Plainsboro, NJ 08536 |
Replacement of a manufacturing vessel. |
| P910023/S152 9/21/07 |
Cadence Family of ICDs | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 |
Addition of an alternate vendor for a component used on the hybrid. |
| P910023/S153 9/28/07 |
Cadence Family of ICDs | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 |
Alternate process to remove cleaning and finishing residue from devices following soda blast and grit blast process. |
| P960040/S149 9/28/07 |
VENTAK AV/VR (VENTAK PRIZM) Devices | Guidant Corporation St. Paul, MN 55112 |
Automation of an adhesive application process. |
| P970003/S087 9/4/07 |
VNS Therapy System | Cyberonics Houston, TX 77058 |
Addition of a new model packaging system for the device. |
| P970003/S088 9/21/07 |
VNS Therapy System Pulse and Pulse Duo Generators | Cyberonics Houston, TX 77058 |
Additional quality control test. |
| P970051/S041 9/21/07 |
Nucleus 24 Cochlear Implant System | Cochlear Americas Englewood, CO 80112 |
Change in biocompatibility information for the Coil spacer (material specification change). |
| P970051/S042 9/21/07 |
Nucleus 24 Cochlear Implant System | Cochlear Americas Englewood, CO 80112 |
Assembly changes for strengthening cable conductor connections. |
| P970051/S043 9/21/07 |
Nucleus 24 Cochlear Implant System | Cochlear Americas Englewood, CO 80112 |
Change in the post-wash drying temperature for the hybrid assembly. |
| P970051/S044 9/21/07 |
Nucleus 24 Cochlear Implant System | Cochlear Americas Englewood, CO 80112 |
Change in the assembly and stylet insertion processes. |
| P980006/S011 9/19/07 |
Bausch & Lomb® PureVision® (balafilcon A) Visibility Tinted Contact Lenses | Bausch & Lomb Rochester, NY 14609 |
Change to the raw material specification for one of the components in the polymer formulation for the contact lens material balafilcon A. |
| P980016/S105 9/12/07 |
Dual Chamber ICDs and CRTs | Medtronic, Inc. Shoreview, MN 55126 |
Change in the vendor who performs the plasma cleaning process for the patient alert flex circuit. |
| P980016/S106 9/12/07 |
Virtuoso Implantable Cardioverter Defibrillator Devices (ICDs) | Medtronic, Inc. Shoreview, MN 55126 |
Rework process for a component during the manufacturing process. |
| P980016/S107 9/21/07 |
Virtuoso Implantable Cardioverter Defibrillator Devices (ICDs) | Medtronic, Inc. Shoreview, MN 55126 |
Modifications to the hybrid tests used on multiple ICDs and CRT devices. |
| P010012/S156 9/28/07 |
CONTAK CD/ EASYTRAK Devices | Guidant Corporation St. Paul, MN 55112 |
Automation of an adhesive application process. |
| P010031/S074 9/12/07 |
Dual Chamber ICDs and CRTs | Medtronic, Inc. Shoreview, MN 55126 |
Change in the vendor who performs the plasma cleaning process for the patient alert flex circuit. |
| P010031/S075 9/12/07 |
Concerto Cardiac Resynchronization Therapy Devices (CRT-Ds) | Medtronic, Inc. Shoreview, MN 55126 |
Rework process for a component during the manufacturing process. |
| P010031/S077 9/21/07 |
Concerto Cardiac Resynchronization Therapy Devices (CRT-Ds) | Medtronic, Inc. Shoreview, MN 55126 |
Modifications to the hybrid tests used on multiple ICDs and CRT devices. |
| P020026/S040 9/4/07 |
CORDIS CYPHER Sirolimus-eluting Coronary Stent | Cordis Corporation Miami, FL 33012 |
Use of CYPHER OTW Stents for analytical testing performed prior to release into finished goods inventory and for the reserve samples for both the CYPHER Sirolimus-eluting Coronary Stent Rapid Exchange (RX) and Over-the-Wire (OTW) delivery systems. |
| P020026/S041 9/21/07 |
CYPHER ® Sirolimus-eluting Coronary Stent | Cordis Corporation Miami, FL 33012 |
Elimination of visual inspections for loose fibers inside the balloon that are conducted during the Crimp and pack manufacturing process. |
| P020052/S003 9/21/07 |
Response™ CV Cardioversion Electrophysiology Catheter and System Accessory Equipment | St. Jude Medical, Inc. Minnetonka, MN 55345 |
Implementation of newly qualified electrode ring swaging equipment and swaging dies, for swaging electrode rings onto catheter shaft, and performance of preventive cleaning for swaging dies. |
| P020052/S004 9/21/07 |
Response™ CV Catheter | St. Jude Medical, Inc. Minnetonka, MN 55345 |
Modification of the method of tray cleaning used in packaging of the device. |
| P030002/S012 9/26/07 |
crystalens Model AT-45 Accommodating Intraocular Lens | eyeonics, Inc. Aliso Viejo, CA 92656 |
Addition of a change in the raw materials mixing method. |
| P030054/S065 9/21/07 |
Epic HF Family of CRT-Ds | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 |
Addition of an alternate vendor for a component used on the hybrid. |
| P030054/S066 9/28/07 |
Epic HF Family of CRT-Ds | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 |
Alternate process to remove cleaning and finishing residue from devices following soda blast and grit blast process. |
| P040025/S005 9/21/07 |
Cool Cap System | Olympic Medical Corp. Seattle, WA 98108 |
Replacing a mechanical test gauge with an electronic gauge and the release of an Acceptance Test Procedure for the periodic verification of all test fixtures. |
| P040027/S006 9/21/07 |
VIATORR® TIPS Endoprosthesis | W.L. Gore and Associates, Inc. Flagstaff, AZ 86001 |
Change in the testing process for the nitinol wire. |
| P050038/S003 9/27/07 |
Arista™ AH Absorbable Hemostat | Medafor, Inc. Minneapolis, MN 55430 |
Change in the frequency of endotoxin testing on a bulk incoming raw material. |
Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 47
Summary of PMA Originals Under Review
Total Under Review: 73
Total Active: 35
Total On Hold: 38
Number Greater Than 180 Days: 3
Summary of PMA Supplements Under Review
Total Under Review: 427
Total Active: 271
Total On Hold: 156
Number Greater Than 180 Days: 14
Summary of All PMA Submissions Received
Originals: 2
Supplements: 120
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 47
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 118
FDA Time: 101.4 Days MFR Time: 16.6 Days
Updated February 8, 2008
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