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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 14 Results
productcode NIM PMA Number p Decision Date From 1/1/2023 Decision Date To 1/1/2024
 
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Device
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PMA
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Protégé™ GPS™ Self-Expanding Peripheral Stent Syst... MEDTRONIC VASCULAR INC P060001 S038 11/21/2023
ENROUTE® Transcarotid Stent System SILK ROAD MEDICAL, INC P140026 S028 10/16/2023
Protégé™ RX Carotid Stent System, Protégé™ GPS™ Se... MEDTRONIC VASCULAR INC P060001 S036 09/18/2023
Protégé™ RX Carotid Stent System, Protégé™ GPS™ Se... MEDTRONIC VASCULAR INC P060001 S037 09/12/2023
Carotid WALLSTENT Monorail Endoprosthesis Boston Scientific Corp. P050019 S039 08/10/2023
Cordis® PRECISE® Nitinol Stent System Cordis US Corporation P030047 S047 07/27/2023
ENROUTE Transcarotid Stent System SILK ROAD MEDICAL, INC P140026 S027 07/20/2023
ENROUTE® Transcarotid Stent System SILK ROAD MEDICAL, INC P140026 S024 06/16/2023
XACT Carotid Stent System ABBOTT VASCULAR INC. P040038 S042 06/14/2023
Carotid WALLSTENT™ Monorail Endoprosthesis System Boston Scientific Corp. P050019 S038 06/14/2023
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