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 Ct.; Sylmar, CA 91335
• PMA Number: P910023
• Supplement Number: S032
• Date Received: 12/29/1997
• Decision Date: 02/02/1998
• Product Code: LWS
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Other
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for use of Ventritex Contour(TM) Model V-145 and Contour(TM) LT Model V-135 pulse generators with the Medtronic(R) Transvene(R) Leads and changes in the Physician's Manuals.