Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: CADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM
• Classification Name: implantable cardioverter defibrillator (non-crt)
• Applicant: VENTRITEX, INC.
• PMA Number: P910023
• Supplement Number: S031
• Date Received: 09/12/1997
• Decision Date: 11/05/1997
• Product Code: LWS [ Registered Establishments with LWS ]
• Advisory Committee: Anesthesiology
• Supplement Type: normal 180 day track
• Supplement Reason: labeling change - instructions
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval of the ventritex cadence(r) and cadet(r) with the medtronic transvene(r) defibrillation leads.