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 AT500 DDDRP PACING SYSTEM (MODEL AT501) AND MODEL 9968 SOFTWARE
• Generic Name: implantable pacemaker Pulse-generator
• Regulation Number: 870.3610
• Applicant: Medtronic, Inc.; 8200 Coral Sea St. N.E; Ms Mvs11; Mounds View, MN 55112
• PMA Number: P980035
• Supplement Number: S028
• Date Received: 05/01/2003
• Decision Date: 10/03/2003
• Product Code: DXY
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL OF THE POST-APPROVAL STUDY.