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 VR 1210; PLATINIUM VR 1240; PLATINIUM DR 1510; PLATINIUM DR 1540; PLATINIUM CRT-D 1711; PLATINIUM CRT-D 1741
• 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: S098
• Date Received: 12/20/2018
• Decision Date: 03/19/2019
• Product Code: NIK
• Advisory Committee: Cardiovascular
• Supplement Type: Real-Time Process
• Supplement Reason: Change Design/Components/Specifications/Material
• Expedited Review Granted?: No
• Combination Product: Yes
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for updates to the embedded device software.