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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 03/05/2015
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PMA
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THERMOCOOL SMARTTOUCH Bi-Directional Navigation Ca... BIOSENSE WEBSTER, INC. P040036 S073 04/30/2020
EZ Steer ThermoCool Catheter, EZ Steer ThermoCool ... BIOSENSE WEBSTER, INC. P040036 S072 04/16/2020
Celsius Catheter, Celsius RMT Catheter, Celsius FL... Biosense Webster, Inc P950005 S074 04/16/2020
Biosense Webster Cables BIOSENSE WEBSTER, INC. P990071 S043 04/16/2020
Thermocool Smarttouch Bi-Directional Navigation Ca... BIOSENSE WEBSTER, INC. P040036 S071 03/31/2020
Thermocool Smart Touch Bi-Directional and Thermoco... BIOSENSE WEBSTER, INC. P040036 S069 02/26/2020
Celsius Electrophysiology Catheter, Deflectable Ti... Biosense Webster, Inc P950005 S073 02/26/2020
EZ Steer Thermocool NAV Catheter and Navistar Ther... BIOSENSE WEBSTER, INC. P040036 S068 08/02/2019
Celsius Catheter Biosense Webster, Inc P950005 S072 08/02/2019
CoolFlow Irrigation Tubing Set BIOSENSE WEBSTER, INC. P990071 S040 05/08/2019
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