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 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: S039
• Date Received: 02/08/1999
• Decision Date: 03/01/1999
• Product Code: LWS
• Advisory Committee: Cardiovascular
• Supplement Type: Special (Immediate Track)
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval to provide the standard Medic Alert(R) information with the Ventritex implantable cardiovertor defibrillators.