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: MEDTRONIC(R) CAPSURE(R)&CAPSURE(R) SP PACING LEADS
• Generic Name: permanent pacemaker Electrode
• Regulation Number: 870.3680
• Applicant: Medtronic Cardiac Rhythm Disease Management; 8200 Coral Sea St. N.E; Mounds View, MN 55112
• PMA Number: P850089
• Supplement Number: S020
• Date Received: 01/27/1992
• Decision Date: 02/14/1992
• 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