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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 08/26/2016
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PMA
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CELSIUS/EZ STEER Biosense Webster, Inc P950005 S029 03/12/2010
CELSIUS/RMT/EZ STEER/EZ STEER DS/NON-TEMPERATURE S... Biosense Webster, Inc P950005 S034 04/06/2011
CELSIUS™, CELSIUS™DS, CELSIUS™RMT, CELSIUS™THERMOC... Biosense Webster, Inc P950005 S079 04/27/2021
COOLFLOW IRRIGATION PUMP BIOSENSE WEBSTER, INC. P990071 S029 11/19/2014
CoolFlow Irrigation Tubing Set BIOSENSE WEBSTER, INC. P990071 S040 05/08/2019
COOLFLOW TUBING IFU BIOSENSE WEBSTER, INC. P990071 S011 04/07/2010
Deflectable Diagnostic/Ablation Catheter, EZ Steer... Biosense Webster, Inc P950005 S086 06/12/2023
EZ STEER BIOSENSE WEBSTER, INC. P030031 S057 10/09/2013
EZ STEER THERMOCOOL NAV CATHETER, NAVI-STAR ELEC... BIOSENSE WEBSTER, INC. P040036 S029 03/30/2012
EZ STEER THERMOCOOL NAV CATHETER, NAVI-STAR ELEC... BIOSENSE WEBSTER, INC. P030031 S040 03/30/2012
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