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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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11 to 20 of 59 Results
productcode NIQ PMA Number p Decision Date From 1/1/2019 Decision Date To 1/1/2020
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Device
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PMA
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EluNIR Ridaforolimus Eluting Coronary Stent System Medinol, Ltd. P170008 S022 11/07/2019
Promus Premier and Promus Elite Everolimus-Eluting... Boston Scientific Corp. P110010 S170 11/01/2019
Orsiro Sirolimus Eluting Coronary Stent System Biotronik, Inc P170030 S004 10/25/2019
Resolute Integrity Zotarolimus-Eluting Coronary St... Medtronic Vascular P110013 S096 10/22/2019
Resolute Onyx Zotarolimus-Eluting Coronary Stent S... MEDTRONIC VASCULAR P160043 S025 10/22/2019
Resolute Integrity Zotarolimus-Eluting Coronary St... Medtronic Vascular P110013 S095 10/17/2019
Resolute Integrity Zotarolimus-Eluting Coronary St... Medtronic Vascular P110013 S098 10/17/2019
Resolute Onyx Zotarolimus-Eluting Coronary Stent S... MEDTRONIC VASCULAR P160043 S024 10/17/2019
Promus PREMIER Everolimus-Eluting Platinum Chromiu... Boston Scientific Corp. P110010 S169 10/11/2019
EluNIR™ Ridaforolimus Eluting Coronary Stent Syste... Medinol, Ltd. P170008 S021 09/20/2019
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