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: CARBON TIPPED LEAD MODELS 1085S,1085M,& 1085K
• Generic Name: permanent pacemaker Electrode
• Regulation Number: 870.3680
• Applicant: Pacesetter Systems; 15900 Valley View Ct.; P.O. Box 9221; Sylmar, CA 91392
• PMA Number: P800041
• Supplement Number: S010
• Date Received: 10/24/1990
• Decision Date: 12/18/1990
• Product Code: DTB
• 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