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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 26 Results
productcode LWR PMA Number p Decision Date From 1/1/2023 Decision Date To 1/1/2024
 
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PMA
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Epic™ Max Tissue Heart Valves Abbott Medical P040021 S052 03/28/2023
Epic™ Supra Valve, Epic™ Valve, Epic™ Plus Stented... Abbott Medical P040021 S053 10/18/2023
Epic, Epic Supra, Epic Plus, Epic Plus Supra, Epic... Abbott Medical P040021 S055 12/18/2023
Perceval S Sutureless Heart Valve; Perceval Plus S... CORCYM Canada Corp. P150011 S027 03/02/2023
INTUITY Delivery System - Accessories EDWARDS LIFESCIENCES, LLC. P150036 S067 02/14/2023
EDWARDS INTUITY Elite Valve System, Delivery Syste... EDWARDS LIFESCIENCES, LLC. P150036 S068 05/04/2023
EDWARDS INTUITY Elite Valve System EDWARDS LIFESCIENCES, LLC. P150036 S069 04/27/2023
EDWARDS INTUITY Elite Valve System EDWARDS LIFESCIENCES, LLC. P150036 S070 08/22/2023
EDWARDS INTUITY Elite Valve EDWARDS LIFESCIENCES, LLC. P150036 S071 12/11/2023
EDWARDS INTUITY Elite Valve EDWARDS LIFESCIENCES, LLC. P150036 S072 12/06/2023
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