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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 18 Results
productcode LWR PMA Number p Decision Date From 1/1/2021 Decision Date To 1/1/2022
 
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PMA
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Biocor™, Biocor™ Supra, Epic™, Epic™ Supra, Epic™ ... Abbott Medical P040021 S048 12/16/2021
Trifecta™ Valve with Glide Technology (Trifecta GT... Abbott Medical P100029 S045 12/16/2021
EDWARDS INTUITY Elite Valve System EDWARDS LIFESCIENCES, LLC. P150036 S059 11/18/2021
Edwards Pericardial Aortic Bioprosthesis, Edwards ... EDWARDS LIFESCIENCES, LLC. P150048 S059 11/18/2021
Edwards INTUITY Elite Valve EDWARDS LIFESCIENCES, LLC. P150036 S058 10/12/2021
Edwards Pericardial Aortic Bioprosthesis, INSPIRIS... EDWARDS LIFESCIENCES, LLC. P150048 S058 10/12/2021
Epic, Epic Supra and Epic Plus Tissue Heart Valves Abbott Medical P040021 S047 09/17/2021
Edwards INTUITY Elite Valve EDWARDS LIFESCIENCES, LLC. P150036 S056 09/08/2021
Edwards INSPIRIS RESILIA Aortic Valve EDWARDS LIFESCIENCES, LLC. P150048 S057 09/08/2021
EDWARDS INTUITY Elite™ Aortic Valve EDWARDS LIFESCIENCES, LLC. P150036 S055 08/31/2021
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