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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 14 Results
productcode PRC PMA Number p Decision Date From 1/1/2021 Decision Date To 1/1/2022
 
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IN.PACT AV Paclitaxel-coated Percutaneous Translum... Medtronic Vascular Inc. P190008 S007 12/17/2021
Lutonix Drug Coated Balloon PTA Catheter LUTONIX P170003 S024 12/16/2021
IN.PACT® AV Paclitaxel-Coated Percutaneous Translu... Medtronic Vascular Inc. P190008 S017 12/09/2021
Lutonix 018 LUTONIX P170003 S025 12/02/2021
Lutonix 035 Drug Coated Balloon PTA Catheter LUTONIX P170003 S022 09/07/2021
Lutonix 018 Drug Coated Balloon PTA Catheters LUTONIX P170003 S019 08/06/2021
Lutonix 018 Drug Coated Balloon Catheter LUTONIX P170003 S023 08/05/2021
IN.PACT AV Paclitaxel-Coated Percutaneous Translum... Medtronic Vascular Inc. P190008 S016 07/21/2021
Lutonix 018 and 035 Drug Coated Balloon PTA Cathe... LUTONIX P170003 S021 06/03/2021
IN.PACT AV DCB Medtronic Vascular Inc. P190008 S014 05/21/2021
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