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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 45 Results
productcode NIQ PMA Number p Decision Date From 1/1/2022 Decision Date To 1/1/2023
 
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SLENDER Sirolimus-Eluting Coronary Stent Integrate... Svelte Medical Systems, Inc. P210014 S001 04/08/2022
Resolute Integrity Coronary Stent System Medtronic Vascular P110013 S109 07/15/2022
Resolute Integrity Coronary Stent System Medtronic Vascular P110013 S112 01/27/2022
Resolute Integrity Zotarolimus-Eluting Coronary St... Medtronic Vascular P110013 S116 04/19/2022
Resolute Integrity Medtronic Vascular P110013 S117 09/29/2022
Resolute Onyx Coronary Stent Systems MEDTRONIC VASCULAR P160043 S045 07/15/2022
Resolute Onyx Coronary Stent System MEDTRONIC VASCULAR P160043 S048 01/27/2022
Resolute Onyx Zotarolimus-Eluting Coronary Stent S... MEDTRONIC VASCULAR P160043 S055 05/12/2022
Resolute Onyx OTW Zotarolimus-Eluting Coronary Ste... MEDTRONIC VASCULAR P160043 S057 01/13/2022
Resolute Onyx Zotarolimus-Eluting Coronary Stent S... MEDTRONIC VASCULAR P160043 S058 09/15/2022
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