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: PARADYM CRT-D 8750,PARADYM RF CRT-D9750
• Generic Name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
• Applicant: MicroPort CRM S.r.l.; Via Crescentino S.N.; Saluggia 13040
• PMA Number: P060027
• Supplement Number: S054
• Date Received: 09/11/2013
• Decision Date: 09/26/2013
• Product Code: NIK
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
CHANGE IN THE TEST METHODOLOGY EMPLOYED DURING BENCH TESTING OF THE COMPONENTS AND FINISHED DEVICE.