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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 12/21/2014
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Thermocool Smarttouch BIOSENSE WEBSTER, INC. P040036 S078 03/02/2021
EZ Steer Thermocool, EZ Steer Thermocool Bi-Direct... BIOSENSE WEBSTER, INC. P040036 S077 02/02/2021
Celsius, Celsius Flutter, EZ Steer Biosense Webster, Inc P950005 S076 02/02/2021
EZ Steer ThermoCool Nav Deflectable Diagnostic/Ab... BIOSENSE WEBSTER, INC. P040036 S070 01/28/2021
ThermoCool SmartTouch SF Catheters BIOSENSE WEBSTER, INC. P040036 S076 01/22/2021
SmartAblate Irrigation Tubing Set BIOSENSE WEBSTER, INC. P990071 S045 10/01/2020
EZ Steer DS Bi-Directional Electrophysiology Cathe... Biosense Webster, Inc P950005 S075 09/24/2020
nGEN Pump BIOSENSE WEBSTER, INC. P990071 S044 07/17/2020
THERMOCOOL SMARTTOUCH Bi-Directional Navigation Ca... BIOSENSE WEBSTER, INC. P040036 S075 07/10/2020
Thermocool Smarttouch BIOSENSE WEBSTER, INC. P040036 S074 06/26/2020
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