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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 20 Results
productcode ONU PMA Number p Decision Date From 1/1/2023 Decision Date To 1/1/2024
 
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Ranger Paclitaxel-Coated PTA Balloon Catheter Boston Scientific Corporation P190019 S025 12/12/2023
Stellarex™ 0.035” OTW Drug-Coated Angioplasty Ball... The Spectranetics Corp. P160049 S022 12/05/2023
Ranger™ Paclitaxel-Coated PTA Balloon Catheter Boston Scientific Corporation P190019 S026 11/24/2023
IN.PACT Admiral Paclitaxel-Coated Percutaneous Tra... MEDTRONIC Inc. P140010 S076 10/12/2023
Ranger-Over-The-Wire Paclitaxel Coated Balloon Cat... Boston Scientific Corporation P190019 S023 10/05/2023
IN.PACT™ Admiral™ Paclitaxel-Coated Percutaneous T... MEDTRONIC Inc. P140010 S074 09/22/2023
Ranger™ Paclitaxel-Coated PTA Balloon Catheter Boston Scientific Corporation P190019 S024 09/22/2023
Lutonix Drug Coated Balloon PTA Catheter LUTONIX P130024 S043 09/07/2023
IN.PACT Admiral Paclitaxel-Coated Percutaneous Tra... MEDTRONIC Inc. P140010 S075 08/30/2023
Chocolate Touch Paclitaxel Drug-Coated PTA Balloon... TriReme Medical, LLC P210039 S001 08/16/2023
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