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: META MV MODEL 1202 CARDIAC PACING SYSTEM
• Generic Name: implantable pacemaker Pulse-generator
• Regulation Number: 870.3610
• Applicant: St. Jude Medical, Inc.; 15900 Valley View Ct.; Sylmar, CA 91342
• PMA Number: P880038
• Supplement Number: S015
• Date Received: 08/27/1990
• Decision Date: 09/19/1990
• Withdrawal Date: 06/20/2007
• Product Code: DXY
• 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