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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Applicant MicroPort CRM USA Inc. productcode DXY Decision Date To 05/03/2024
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ELA MEDICAL RATE-RESPONSIVE PACEMAKERS MicroPort CRM USA Inc. P950029 S023 02/28/2005
SYMPHONY DR 2550 MODE AND ELAVIEW 1.28 UG1 PROGRAM... MicroPort CRM USA Inc. P950029 S022 04/27/2005
SYMPHONY/ELA RHAPSODY PACEMAKER SYSTEM AND THE ORC... MicroPort CRM USA Inc. P950029 S024 09/02/2005
Reply SR, Reply DR, Esprit SR, Esprit DR MicroPort CRM USA Inc. P950029 S109 03/01/2016
REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR Pacemaker... MicroPort CRM USA Inc. P950029 S110 06/22/2016
Platinium, Paradym RF, RF VR, RF DR, Intensia CRT-... MicroPort CRM USA Inc. P060027 S083 09/27/2016
Reply Sr, Reply DR, Esprit SR, Esprit DR Pacemaker... MicroPort CRM USA Inc. P950029 S111 09/27/2016
Platinum VR/DR ICDS,Paradym RF VR/ RF DR CRT-Ds, I... MicroPort CRM USA Inc. P980049 S117 09/27/2016
Repy SR/DR & Esprit SR/DR Pacemakers MicroPort CRM USA Inc. P950029 S112 10/25/2016
Reply/Esprit Pacemakers Sorin CRM. MicroPort CRM USA Inc. P950029 S113 12/16/2016
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