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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 10 Results
productcode PRC PMA Number p Decision Date From 1/1/2020 Decision Date To 1/1/2021
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IN.PACT AV Paclitaxel-Coated Percutaneous Translum... Medtronic Vascular Inc. P190008 S008 11/24/2020
IN.PACT AV Paclitaxel-coated Percutaneous Translum... Medtronic Vascular Inc. P190008 S006 10/14/2020
IN.PACT AV Paclitaxel-coated Percutaneous Translum... Medtronic Vascular Inc. P190008 S004 09/24/2020
IN.PACT AV Paclitaxel-Coated Percutaneous Translum... Medtronic Vascular Inc. P190008 S005 09/11/2020
IN.PACT AV Paclitaxel-Coated Percutaneous Translum... Medtronic Vascular Inc. P190008 S003 06/25/2020
Lutonix 035 Drug Coated Balloon PTA Catheter LUTONIX P170003 S017 05/14/2020
Lutonix 018 Drug Coated Balloon PTA Catheter LUTONIX P170003 S018 05/04/2020
Lutonix 018 Drug Coated Balloon PTA Catheter (Luto... LUTONIX P170003 S016 04/21/2020
IN.PACT AV Paclitaxel-coated Percutaneous Translum... Medtronic Vascular Inc. P190008 S001 04/10/2020
In.Pact AV Paclitaxel-Coated PTA Balloon Catheter Medtronic Vascular Inc. P190008 S002 02/20/2020
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