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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 15 Results
productcode ONU PMA Number p Decision Date From 1/1/2019 Decision Date To 1/1/2020
 
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Lutonix 018 Drug Coated Balloon PTA Catheter (Luto... LUTONIX P130024 S030 12/19/2019
Lutonix 018 Drug Coated Balloon PTA Catheters LUTONIX P130024 S032 12/18/2019
IN.PACT Admiral Paclitaxel-Coated Percutaneous Tra... MEDTRONIC Inc. P140010 S048 12/17/2019
Stellarex 0.035 OTW Drug-coated Angioplasty Balloo... The Spectranetics Corp. P160049 S004 10/11/2019
Lutonix Drug Coated Balloon PTA Catheter LUTONIX P130024 S029 09/13/2019
In.Pact Admiral Paclitaxel-coated Percutaneous Tra... MEDTRONIC Inc. P140010 S047 09/13/2019
Stellarex 0.035 OTW Drug-coated Angioplasty Ballon The Spectranetics Corp. P160049 S007 09/13/2019
IN.PACT Admiral Paclitaxel-Coated Percutaneous Tra... MEDTRONIC Inc. P140010 S046 06/27/2019
Stellarex 0.035 OTW Drug-coated Angioplasty Balloo... The Spectranetics Corp. P160049 S006 06/12/2019
Lutonix 018 Drug Coated Balloon PTA Catheter (Luto... LUTONIX P130024 S027 05/23/2019
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