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: Platinium CRT-D and Platinium 4LV CRT-D (Cardiac Resynchronization Therapy Defibrillator)
• 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: S102
• Date Received: 02/10/2020
• Decision Date: 03/06/2020
• Product Code: NIK
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Implement sterilization cycle MicroPort01 at Steris SpA contactor.