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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 17 Results
productcode NIM PMA Number p Decision Date From 1/1/2022 Decision Date To 1/1/2023
 
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PMA
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Cordis® PRECISE® Nitinol Stent Systems Cordis US Corporation P030047 S046 12/16/2022
ENROUTE® Transcarotid Stent System SILK ROAD MEDICAL, INC P140026 S025 12/16/2022
ENROUTE Transcarotid Stent System SILK ROAD MEDICAL, INC P140026 S026 12/16/2022
Protégé GPS Self-Expanding Peripheral Stent System... MEDTRONIC VASCULAR INC P060001 S035 12/15/2022
Cordis® PRECISE® Nitinol Stent System Cordis US Corporation P030047 S045 12/07/2022
Carotid WALLSTENT™ Monorail Endoprosthesis System Boston Scientific Corp. P050019 S036 11/28/2022
ENROUTE Transcarotid Stent System SILK ROAD MEDICAL, INC P140026 S023 08/19/2022
ENROUTE Transcarotid Stent System SILK ROAD MEDICAL, INC P140026 S020 07/20/2022
XACT Carotid Stent System ABBOTT VASCULAR INC. P040038 S040 07/13/2022
ENROUTE® Transcarotid Stent System SILK ROAD MEDICAL, INC P140026 S021 06/24/2022
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