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 pacemaker Pulse-generator
• Regulation Number: 870.3610
• Applicant: Abbott Medical; 15900 Valley View Court; Sylmar, CA 91335
• PMA Number: P910023
• Supplement Number: S075
• Date Received: 09/08/2004
• Decision Date: 01/19/2005
• Product Code: DXY
• 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

Approval Order Statement  
APPROVAL FOR LABELING MODIFICATIONS TO DESCRIBE THE PROTOCOL AND RESULTS FROM THE DEFINITE CLINICAL TRIAL.