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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 16 Results
productcode NIO PMA Number p Decision Date From 1/1/2022 Decision Date To 1/1/2023
 
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Cordis® PALMAZ® Balloon-Expandable Stent Cordis US Corporation P890017 S023 12/20/2022
Cordis® S.M.A.R.T.® CONTROL® Nitinol Stent Systems... Cordis US Corporation P020036 S048 12/16/2022
Cordis® S.M.A.R.T.® CONTROL® Vascular Stent System Cordis US Corporation P020036 S047 12/07/2022
Express® LD Iliac Premounted Stent System BOSTON SCIENTIFIC CORPORATION P090003 S053 11/28/2022
WALLSTENT™ ILIAC RP Endoprosthesis BOSTON SCIENTIFIC SCIMED, INC. P940019 S062 11/28/2022
WALLSTENT™ ILIAC RP Endoprosthesis BOSTON SCIENTIFIC SCIMED, INC. P940019 S061 11/22/2022
EPIC Vascular Self-Expanding Stent System Boston Scientific Corp. P110035 S068 11/07/2022
Omnilink Elite™ Vascular Balloon-Exoandable Stent ... ABBOTT VASCULAR-CARDIAC THERAP P110043 S013 09/07/2022
Express® LD Iliac Premounted Stent System BOSTON SCIENTIFIC CORPORATION P090003 S052 08/25/2022
Astron Peripheral Self-Expanding Nitinol Stent Sys... BIOTRONIK, INC. P140030 S015 07/27/2022
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