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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 55 Results
productcode LKK 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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Prometra Programmable Infusion Pump System FLOWONIX MEDICAL, INC. P080012 S053 12/17/2018
Implantable System for Remodulin Medtronic, Inc. P140032 S022 11/29/2018
SynchroMed Infusion System, Intrathecal Catheters MEDTRONIC Inc. P860004 S320 11/27/2018
Implantable System for Remodulin Medtronic, Inc. P140032 S021 11/13/2018
SynchroMed Infusion System, Ascenda Intrathecal Ca... MEDTRONIC Inc. P860004 S318 11/13/2018
Codman 3000 Series Constant-Flow Implantable Infus... Intera Oncology P890055 S072 11/06/2018
SynchroMed Infusion System, Ascenda Intrathecal Ca... MEDTRONIC Inc. P860004 S317 10/12/2018
Implantable System for Remodulin Medtronic, Inc. P140032 S019 09/12/2018
Implantable System for Remodulin Medtronic, Inc. P140032 S005 09/06/2018
Implantable System for Remodulin Medtronic, Inc. P140032 S017 08/24/2018
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