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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 8 of 8 Results
productcode NIM PMA Number p Decision Date From 1/1/2017 Decision Date To 1/1/2018
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Device
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Applicant
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PMA
Number
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Decision
Date
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Cordis Precise Nitinol Stent System Cordis US Corporation P030047 S034 12/15/2017
Protege GPS and Protege RX Carotid Stent System; P... MEDTRONIC VASCULAR INC P060001 S026 11/27/2017
ENROUTE TRANSCAROTID STENT SYSTEM SILK ROAD MEDICAL, INC P140026 S005 07/18/2017
Carotid Wallstent Monorail Endoprothesis plus deli... Boston Scientific Corp. P050019 S028 07/03/2017
Enroute Transcarotid Stent System SILK ROAD MEDICAL, INC P140026 S006 04/13/2017
Rx Acculink Carotid Stent System ABBOTT VASCULAR P040012 S059 04/07/2017
ENROUTE TRANSCAROTID STENT SYSTEM SILK ROAD MEDICAL, INC P140026 S004 01/26/2017
ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CARO... ABBOTT VASCULAR P040012 S057 01/05/2017
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