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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 10/22/2014
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CELSIUS Biosense Webster, Inc P950005 S082 03/08/2022
Celsius FLTR (Flutter) Catheter, Celsius Electroph... Biosense Webster, Inc P950005 S081 07/09/2021
CELSIUS DS, NAVISTAR DS, EZ STEER DS and CELSIUS F... Biosense Webster, Inc P950005 S080 09/22/2021
CELSIUS™, CELSIUS™DS, CELSIUS™RMT, CELSIUS™THERMOC... Biosense Webster, Inc P950005 S079 04/27/2021
Biosense Webster Cables, Celsius Catheter, Celsius... Biosense Webster, Inc P950005 S078 04/28/2021
Celsius, Celsius RMT, EZ Steer Bi-directional non ... Biosense Webster, Inc P950005 S077 04/07/2021
Celsius, Celsius Flutter, EZ Steer Biosense Webster, Inc P950005 S076 02/02/2021
EZ Steer DS Bi-Directional Electrophysiology Cathe... Biosense Webster, Inc P950005 S075 09/24/2020
Celsius Catheter, Celsius RMT Catheter, Celsius FL... Biosense Webster, Inc P950005 S074 04/16/2020
Celsius Electrophysiology Catheter, Deflectable Ti... Biosense Webster, Inc P950005 S073 02/26/2020
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