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: VENTAK P MODEL 1600
• Classification Name: implantable cardioverter defibrillator (non-crt)
• Applicant: CARDIAC PACEMAKERS, INC.
• PMA Number: P890061
• Supplement Number: S005
• Date Received: 08/26/1992
• Decision Date: 09/24/1992
• Product Code: LWS [ Registered Establishments with LWS ]
• Advisory Committee: Cardiovascular
• Supplement Type: normal 180 day track
• Supplement Reason: labeling change - other
• Expedited Review Granted?: No
• Combination Product: No