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: PROTECTA XT/PROTECTA/CONSULTA/MAXIMO II CRT-D DF4
• Generic Name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
• Applicant: Medtronic Cardiac Rhythm Disease Management; 8200 Coral Sea St. N.E; Mounds View, MN 55112
• PMA Number: P010031
• Supplement Number: S305
• Date Received: 05/02/2012
• Decision Date: 09/17/2012
• Product Code: NIK
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol - OSB
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.