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U.S. Department of Health and Human Services

Premarket Approval - PMA
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Device Name
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PMA
Number
Sort by PMA Number [0-9]
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Decision
Date
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venaseal closure system MEDTRONIC VASCULAR INC P140018S038 09/06/2023
inspire implantable pulse generator (ipg) INSPIRE MEDICAL SYSTEMS P130008S088 08/19/2022
perceval s sutureless heart valve, perceval plus sutureless heart valve CORCYM Canada Corp. P150011S023 03/07/2022
transvene cs/svc lead MEDTRONIC Inc. P980050S133 06/23/2021
parvovirus b19 igg enzyme immunoassay DIASORIN P970054S019 08/13/2020
psw 1904.u BIOTRONIK, INC. P050023S145 05/29/2020
freezor, arctic front advance (afa) cryoablation catheters Medtronic CryoCath LP P020045S093 02/03/2020
cobas kras mutation test Roche Molecular Systems, Inc. P140023S018 12/07/2018
carotid wallstent monorail endoprosthesis Boston Scientific Corp. P050019S029 02/22/2018
myocardial pacing lead MEDTRONIC Inc. P120017S011 12/14/2017

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