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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Applicant BIOSENSE WEBSTER, INC productcode LPB Decision Date To 05/27/2015
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PMA
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WEBSTER Catheter / CELSIUS Catheter Biosense Webster, Inc P950005 S069 03/28/2018
Webster Electrophysiology Catheter, Celsius Electr... Biosense Webster, Inc P950005 S070 07/30/2018
Celsius RMT Catheter; Navistar RMT Thermocool Cath... Biosense Webster, Inc P950005 S071 03/08/2019
Celsius Catheter Biosense Webster, Inc P950005 S072 08/02/2019
Celsius Electrophysiology Catheter, Deflectable Ti... Biosense Webster, Inc P950005 S073 02/26/2020
Celsius Catheter, Celsius RMT Catheter, Celsius FL... Biosense Webster, Inc P950005 S074 04/16/2020
EZ Steer DS Bi-Directional Electrophysiology Cathe... Biosense Webster, Inc P950005 S075 09/24/2020
Celsius, Celsius Flutter, EZ Steer Biosense Webster, Inc P950005 S076 02/02/2021
Celsius, Celsius RMT, EZ Steer Bi-directional non ... Biosense Webster, Inc P950005 S077 04/07/2021
Biosense Webster Cables, Celsius Catheter, Celsius... Biosense Webster, Inc P950005 S078 04/28/2021
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