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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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11 to 20 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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Edwards Commander Delivery System EDWARDS LIFESCIENCES, LLC. P140031 S056 11/13/2017
Edwards Expandable Introducer Sheath Set EDWARDS LIFESCIENCES, LLC. P130009 S082 10/04/2017
Edwards SAPIEN 3 Transcatheter Heart Valve EDWARDS LIFESCIENCES, LLC. P140031 S053 10/04/2017
Evolut R Transcatheter Aortic Valve (TAV) Medtronic, Inc. P130021 S042 10/03/2017
Edwards Commander Delivery System EDWARDS LIFESCIENCES, LLC. P140031 S054 10/03/2017
Sapien 3 Transcatheter Heart Valve EDWARDS LIFESCIENCES, LLC. P140031 S052 09/28/2017
En Veo R Delivery Catheter System Medtronic, Inc. P130021 S040 08/31/2017
Edwards Crimper model 9600CR EDWARDS LIFESCIENCES, LLC. P140031 S041 08/15/2017
Sapien 3 - Transcatheter Heart Valve and Accessori... EDWARDS LIFESCIENCES, LLC. P140031 S051 08/15/2017
Edwards SAPIEN XT Transcatheter Heart Valve EDWARDS LIFESCIENCES, LLC. P130009 S081 07/28/2017
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