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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 13 Results
productcode NIM PMA Number p Decision Date From 1/1/2021 Decision Date To 1/1/2022
 
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Carotid Wallstent™ Monorail Endoprosthesis Boston Scientific Corp. P050019 S033 12/10/2021
RX Acculink Carotid Stent System ABBOTT VASCULAR P040012 S063 12/08/2021
XACT Carotid Stent System ABBOTT VASCULAR INC. P040038 S039 12/08/2021
XACT Carotid Stent System ABBOTT VASCULAR INC. P040038 S038 11/24/2021
Carotid Wallstent™ Monorail Endoprosthesis Boston Scientific Corp. P050019 S032 11/15/2021
ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CARO... ABBOTT VASCULAR P040012 S062 10/12/2021
Acculink Carotid Stent System ABBOTT VASCULAR P040012 S061 06/16/2021
Protégé RX Self-expanding Stent System, Protégé GP... MEDTRONIC VASCULAR INC P060001 S032 05/07/2021
ENROUTE® Transcarotid Stent System SILK ROAD MEDICAL, INC P140026 S018 05/05/2021
PRECISE Pro Rx Nitinol Stent System Cordis US Corporation P030047 S041 04/01/2021
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