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: S033
• Date Received: 05/22/1998
• Decision Date: 10/21/1998
• Product Code: LWS
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/Components/Specifications/Material
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval of the Ventritex(R) Contour(R) MD Models V-175, V-175B, V-175C, V-175D and V-175AC and the Angstrom(TM) MD Models v-190F and V-190HV3.