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: CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM
• Generic Name: Implantable cardioverter defibrillator (non-CRT)
• Applicant: Abbott Medical; 15900 Valley View Court; Sylmar, CA 91335
• PMA Number: P910023
• Supplement Number: S031
• Date Received: 09/12/1997
• Decision Date: 11/05/1997
• Product Code: LWS
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Recalls: CDRH Recalls

Approval Order Statement  
Approval of the Ventritex Cadence(R) and Cadet(R) with the Medtronic Transvene(R) defibrillation leads.