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: CONCERTO II CRT-D. CONSULTA DF-4 ICD, CONSULTA ICD, MAXIMO II CRT-D, MAXIMO II DF-4 CRT-D, PROTECTA CRT-D, PROTECTA DF4
• Applicant: Medtronic Cardiac Rhythm Disease Management; 8200 Coral Sea St. N.E; Mounds View, MN 55112
• PMA Number: P010031
• Supplement Number: S332
• Date Received: 08/23/2012
• Decision Date: 09/20/2012
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
UPDATE ACCEPTANCE CRITERIA INSPECTION PROCESS FOR ALL DIE LOCATIONS ON ALL HYBRIDS.