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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 49 Results
productcode LKK PMA Number p Decision Date From 1/1/2020 Decision Date To 1/1/2021
 
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Device
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PMA
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Prometra Programmable Infusion Pump System FLOWONIX MEDICAL, INC. P080012 S056 12/30/2020
Implantable System for Remodulin Medtronic, Inc. P140032 S064 12/18/2020
SynchroMed Infusion System and Ascenda Intrathecal... MEDTRONIC Inc. P860004 S366 12/18/2020
Codman OR Prep Kits Intera Oncology P890055 S076 12/16/2020
Implantable System for Remodulin Medtronic, Inc. P140032 S063 11/30/2020
SynchroMed Infusion System MEDTRONIC Inc. P860004 S365 11/30/2020
Implantable System for Remodulin Medtronic, Inc. P140032 S062 11/19/2020
SynchroMed Infusion System, Ascenda Intrathecal Ca... MEDTRONIC Inc. P860004 S364 11/19/2020
Implantable System for Remodulin Medtronic, Inc. P140032 S061 11/18/2020
SynchroMed Intrathecal Catheters MEDTRONIC Inc. P860004 S363 11/18/2020
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