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: INSYNC SENTRY CRT-D/CONCERTO ICD/CONSULTA CRT-D/CONCERTO II CRT-D/MAXIMO II CRT-D
• Applicant: Medtronic Cardiac Rhythm Disease Management; 8200 Coral Sea St. N.E; Mounds View, MN 55112
• PMA Number: P010031
• Supplement Number: S238
• Date Received: 02/18/2011
• Decision Date: 03/17/2011
• 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 TO THE STERILE PACKAGING OPERATION PROCESS.