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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 ONU PMA Number p Decision Date From 1/1/2017 Decision Date To 1/1/2018
 
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Lutonix Drug Coated Balloon LUTONIX P130024 S020 11/28/2017
Stellarex 0.035 OTW Drug-coated Angioplasty Balloo... The Spectranetics Corp. P160049 S001 10/23/2017
IN.PACT Admiral Paclitaxel-Coated Balloon Catheter MEDTRONIC Inc. P140010 S036 08/17/2017
IN.PACT Admiral Paclitaxel-Coated Balloon Catheter MEDTRONIC Inc. P140010 S035 07/28/2017
STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOO... The Spectranetics Corp. P160049 07/26/2017
IN PACT Admiral Paclitarel-Coated Balloon Catheter MEDTRONIC Inc. P140010 S032 07/05/2017
IN.Pact Admiral Paclitaxel-Coated Ballon Catheter MEDTRONIC Inc. P140010 S034 06/23/2017
IN.PACT Admiral Paclitaxel-Coated Balloon Catheter MEDTRONIC Inc. P140010 S031 05/08/2017
IN.PACT Admiral Paclitaxel-Coated Balloon Catheter MEDTRONIC Inc. P140010 S030 03/30/2017
IN.PACT Admiral Paclitaxel-Coated Percutaneous Tra... MEDTRONIC Inc. P140010 S029 03/16/2017
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