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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 Center Devices Decision Date To 07/26/2016
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CELSIUS™, CELSIUS™DS, CELSIUS™RMT, CELSIUS™THERMOC... Biosense Webster, Inc P950005 S079 04/27/2021
CELSIUS DS, NAVISTAR DS, EZ STEER DS and CELSIUS F... Biosense Webster, Inc P950005 S080 09/22/2021
Celsius FLTR (Flutter) Catheter, Celsius Electroph... Biosense Webster, Inc P950005 S081 07/09/2021
CELSIUS Biosense Webster, Inc P950005 S082 03/08/2022
Biosense Webster Cables, Celsius Catheter, Celsius... Biosense Webster, Inc P950005 S083 09/22/2021
CELSIUS Biosense Webster, Inc P950005 S084 09/09/2022
Celsius Catheter, Celsius RMT Catheter, Celsius FL... Biosense Webster, Inc P950005 S085 09/30/2022
Deflectable Diagnostic/Ablation Catheter, EZ Steer... Biosense Webster, Inc P950005 S086 06/12/2023
NAVISTAR THERMOCOOL AND CELSIUS THERMOCOOL DEFLECT... BIOSENSE WEBSTER, INC. P030031 S004 04/23/2007
NAVISTAR RMT THERMOCOOL DIAGNOSTIC/ABLATION DEFLEC... BIOSENSE WEBSTER, INC. P030031 S005 01/04/2008
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