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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 64 Results
productcode LWR PMA Number p Decision Date From 1/1/2018 Decision Date To 1/1/2019
 
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Device
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PMA
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Edwards Pericardial Aortic Bioprosthesis and INSPI... EDWARDS LIFESCIENCES, LLC. P150048 S023 12/28/2018
Medtronic CoreValve Evolut PRO TAV, and Avalus Bio... Medtronic Inc. P170006 S008 12/06/2018
EDWARDS INTUITY Elite Valve System EDWARDS LIFESCIENCES, LLC. P150036 S035 12/03/2018
Edwards Pericardial Aortic Bioprosthesis and Edwar... EDWARDS LIFESCIENCES, LLC. P150048 S030 12/03/2018
EDWARDS INTUITY ELITE Valve/Delivery System EDWARDS LIFESCIENCES, LLC. P150036 S036 12/01/2018
EDWARDS INTUITY Elite Valve System EDWARDS LIFESCIENCES, LLC. P150036 S033 11/20/2018
Edwards Pericardial Aortic Bioprosthesis and Edwar... EDWARDS LIFESCIENCES, LLC. P150048 S027 11/20/2018
EDWARDS INTUITY Elite Valve System EDWARDS LIFESCIENCES, LLC. P150036 S034 11/19/2018
Edwards Pericardial Aortic Bioprosthesis and Edwar... EDWARDS LIFESCIENCES, LLC. P150048 S028 11/19/2018
Trifecta Valve with Glide Technology (Trifecta GT)... Abbott Medical P100029 S037 11/14/2018
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