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: MODEL K (UNIPOLAR) & M (BIPOLAR) ENDOCARDIAL LEADS
• Generic Name: implantable pacemaker Pulse-generator
• Regulation Number: 870.3610
• Applicant: Cook Pacemaker Corp.; Rte. 66 River Rd.; P.O. Box 529; Leechburg, PA 15656
• PMA Number: P870054
• Supplement Number: S009
• Date Received: 12/20/1989
• Decision Date: 10/31/1990
• Withdrawal Date: 12/01/2004
• Product Code: DXY
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/Components/Specifications/Material
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No