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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 NIK
 
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PMA
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Smart Monitor, Smart Spot, SmartView Monitor, Smar... MicroPort CRM USA Inc. P060027 S105 08/13/2021
Platinium CRT-D and Platinium 4LV CRT-D (Cardiac R... MicroPort CRM USA Inc. P060027 S104 10/20/2020
Platinium CRT-D and Platinium 4LV CRT-D MicroPort CRM USA Inc. P060027 S103 08/10/2020
Cardiac Resynchronization Therapy-Defibrillator (C... MicroPort CRM USA Inc. P060027 S101 06/24/2020
Platinium CRT-D and Platinium 4LV CRT-D (Cardiac R... MicroPort CRM USA Inc. P060027 S102 03/06/2020
Platinium 4LV CRT-D MicroPort CRM USA Inc. P060027 S100 12/04/2019
PLATINIUM VR 1210; PLATINIUM VR 1240; PLATINIUM DR... MicroPort CRM USA Inc. P060027 S098 03/19/2019
Cardiac Resynchronization Therapy Defibrillator MicroPort CRM USA Inc. P060027 S099 03/05/2019
CRT-Ds (Cardiac Resynchronization Therapy Defibril... MicroPort CRM USA Inc. P060027 S097 12/06/2018
Paradym CRT-D, Paradym RF CRT-D (ZL 102), Intensia... MicroPort CRM USA Inc. P060027 S096 05/14/2018
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