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, Paradym RF, RF VR, RF DR, Intensia CRT-Ds
• Generic Name: implantable pacemaker Pulse-generator
• Regulation Number: 870.3610
• Applicant: MicroPort CRM S.r.l.; Via Crescentino S.N.; Saluggia 13040
• PMA Number: P060027
• Supplement Number: S083
• Date Received: 07/21/2016
• Decision Date: 09/27/2016
• Product Code: DXY
• 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 Remote Monitoring System software version 3.7.