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: TVL LEAD SYSTEM
• Generic Name: Implantable cardioverter defibrillator (non-CRT)
• Applicant: ABBOTT MEDICAL; 15900 Valley View Ct.; Sylmar, CA 91335
• PMA Number: P950022
• Supplement Number: S011
• Date Received: 08/17/2000
• Decision Date: 09/25/2000
• Product Code: LWS
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Express GMP Supplement
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY FOR LEAD PROCESSING AT ST. JUDE MEDICAL, SYLMAR, CALIFORNIA.