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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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productcode NIQ PMA Number p Decision Date From 1/1/2024 Decision Date To 1/1/2025
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PMA
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Orsiro Mission Sirolimus Eluting Coronary Stent Sy... Biotronik, Inc P170030 S037 04/24/2024
Resolute Onyx Zotarolimus-Eluting Coronary Stent S... MEDTRONIC VASCULAR P160043 S079 04/11/2024
Resolute Onyx Zotarolimus-Eluting Coronary Stent S... MEDTRONIC VASCULAR P160043 S080 04/10/2024
EluNIR-PERL Ridaforolimus Eluting Coronary Stent S... Medinol, Ltd. P170008 S048 04/10/2024
Orsiro Mission Sirolimus Eluting Coronary Stent Sy... Biotronik, Inc P170030 S036 03/26/2024
Resolute Onyx Rapid Exchange Zotarolimus- Eluting ... MEDTRONIC VASCULAR P160043 S078 03/08/2024
XIENCE Alpine Everolimus Eluting Coronary Stent Sy... ABBOTT VASCULAR P110019 S132 02/15/2024
Resolute Onyx RX Zotarolimus-Eluting Coronary Sten... MEDTRONIC VASCULAR P160043 S077 02/12/2024
SYNERGY™ Everolimus-Eluting Platinum Chromium Coro... BOSTON SCIENTIFIC CORPORATION P150003 S096 01/19/2024
XIENCE PRIME™ Everolimus Eluting Coronary Stent Sy... ABBOTT VASCULAR P110019 S131 01/17/2024
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