Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: ST JUDE MEDICAL FRONTIER/FRONTIER II CRT-PS
• Generic Name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
• Applicant: ABBOTT MEDICAL; 15900 Valley View Ct.; Sylmar, CA 91335
• PMA Number: P030035
• Supplement Number: S050
• Date Received: 12/18/2008
• Decision Date: 01/16/2009
• Product Code: NKE
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
CHANGES TO THE CLEANING PROCESS USED FOR FEEDTHROUGH AND HYBRID CERAMIC SUBSTRATES AT THE COMPONENT VENDOR.