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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 11 Results
productcode NIM PMA Number p Decision Date From 1/1/2019 Decision Date To 1/1/2020
 
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PMA
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ENROUTE Transcarotid Stent System SILK ROAD MEDICAL, INC P140026 S013 09/04/2019
CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS Boston Scientific Corp. P050019 S031 07/25/2019
PRECISE PRO RX Nitinol Stent System Cordis US Corporation P030047 S039 06/21/2019
Protégé GPS and Protégé RX Carotid Stent Systems, ... MEDTRONIC VASCULAR INC P060001 S028 06/17/2019
Protege RX Carotid Stent Systems and Protege GPS P... MEDTRONIC VASCULAR INC P060001 S027 05/23/2019
Cordis PRECISE Nitinol Stent System Cordis US Corporation P030047 S038 04/30/2019
ENROUTE TRANSCAROTID STENT SYSTEM SILK ROAD MEDICAL, INC P140026 S012 04/30/2019
GORE Carotid Stent W. L Gore & Associates, Inc P180010 S004 03/18/2019
XACT Carotid Stent System ABBOTT VASCULAR INC. P040038 S035 03/14/2019
GORE Carotid Stent W. L Gore & Associates, Inc P180010 S003 03/06/2019
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