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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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EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE EDWARDS LIFESCIENCES, LLC. P130009 S069 01/19/2017
SAPIEN 3 TRANSCATHETER HEART VALVE EDWARDS LIFESCIENCES, LLC. P140031 S029 01/19/2017
QUALCRIMP CRIMPING ACCESSORY (LAMINATED) EDWARDS LIFESCIENCES, LLC. P140031 S031 02/27/2017
EDWARDS COMMANDER DELIVERY SYSTEM EDWARDS LIFESCIENCES, LLC. P140031 S030 03/01/2017
SAPIEN XT Transcatheter Heart Valve (Frame only) A... EDWARDS LIFESCIENCES, LLC. P130009 S070 03/09/2017
Medtronic CoreValve System/Medtronic Evolut R Syst... Medtronic, Inc. P130021 S030 03/09/2017
SAPIEN 3 Transcatheter Heart Valve (Frame only) Co... EDWARDS LIFESCIENCES, LLC. P140031 S032 03/09/2017
Medtronic CoreValve Evolut PRO System Medtronic, Inc. P130021 S029 03/20/2017
Edwards SAPIEN XT Transcatheter Heart Valve EDWARDS LIFESCIENCES, LLC. P130009 S068 04/03/2017
Sapien 3 Transcatheter Heart Valve and Accessories EDWARDS LIFESCIENCES, LLC. P140031 S033 04/03/2017
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