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 CAPSURE SP MODEL 4523M
• 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: P830061
• Supplement Number: S029
• Date Received: 09/01/1998
• Decision Date: 10/09/1998
• Product Code: DTB
• 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

Approval Order Statement  
Approval for removing the platinum sputtering from the conductor coil of the device.