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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 12 Results
productcode ONU PMA Number p Decision Date From 1/1/2018 Decision Date To 1/1/2019
 
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PMA
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Lutonix 035 Drug Coated Balloon PTA Catheter (Luto... LUTONIX P130024 S025 12/18/2018
IN.PACT Admiral Paclitaxel-Coated Percutaneous Tra... MEDTRONIC Inc. P140010 S043 11/16/2018
STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOO... The Spectranetics Corp. P160049 S003 11/16/2018
IN.PACT Admiral Paclitaxel-Coatede Percutaneous Tr... MEDTRONIC Inc. P140010 S041 10/05/2018
Lutonix 035 Drug Coated Balloon PTA Catheter (Luto... LUTONIX P130024 S024 09/10/2018
Lutonix 035 Drug Coated Balloon PTA Catheter (Luto... LUTONIX P130024 S022 08/29/2018
Lutonix Drug Coated Ballon LUTONIX P130024 S023 06/28/2018
IN.PACT Admiral Paclitaxel-Coated Percutaneous Tra... MEDTRONIC Inc. P140010 S039 05/25/2018
IN.PACT Admiral Paclitaxel-Coated Percutaneous-Tra... MEDTRONIC Inc. P140010 S037 04/19/2018
Stellarex 0.035 OTW Drug-coated Angioplasty Balloo... The Spectranetics Corp. P160049 S002 03/12/2018
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