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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 65 Results
productcode NPT PMA Number p Decision Date From 1/1/2017 Decision Date To 1/1/2018
 
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Device
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PMA
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Ascendra+ Delivery System; Balloon Aortic Valvulop... EDWARDS LIFESCIENCES, LLC. P130009 S080 07/27/2017
Commander Delivery System; Certitude Delivery Syst... EDWARDS LIFESCIENCES, LLC. P140031 S049 07/27/2017
Core Valve Evolut R System and Core Valve Evolut P... Medtronic, Inc. P130021 S048 12/12/2017
CoreValve Evolut R System and CoreValve Evolut Pro... Medtronic, Inc. P130021 S047 12/11/2017
CoreValve Evolut R System and CoreValve Evolut PRO... Medtronic, Inc. P130021 S046 11/21/2017
CoreValve System; CoreValve Evolut R System; CoreV... Medtronic, Inc. P130021 S033 07/10/2017
CoreValve, Evolut-R Evolut PRO Medtronic, Inc. P130021 S045 11/16/2017
EDWARDS COMMANDER DELIVERY SYSTEM EDWARDS LIFESCIENCES, LLC. P140031 S030 03/01/2017
Edwards Commander Delivery System EDWARDS LIFESCIENCES, LLC. P140031 S056 11/13/2017
Edwards Commander Delivery System EDWARDS LIFESCIENCES, LLC. P140031 S037 04/19/2017
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