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: Reply SR and Reply 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: S126
• Date Received: 07/13/2020
• Decision Date: 08/10/2020
• 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  
Introduction of automated equipment during the manufacturing of select pacemakers and defibrillators.