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: Repy SR/DR & Esprit SR/DR Pacemakers
• Generic Name: implantable pacemaker Pulse-generator
• Regulation Number: 870.3610
• Applicant: MicroPort CRM S.r.l.; Via Crescentino S.N.; Saluggia 13040
• PMA Number: P950029
• Supplement Number: S112
• Date Received: 10/01/2016
• Decision Date: 10/25/2016
• Product Code: DXY
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Process updates in the microelectronics assembly manufacturing line and the addition of new equipment for resin coating.