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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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Thermocool Smarttouch BIOSENSE WEBSTER, INC. P040036 S074 06/26/2020
Thermocool Smarttouch BIOSENSE WEBSTER, INC. P040036 S094 05/03/2023
THERMOCOOL SMARTTOUCH BIOSENSE WEBSTER, INC. P040036 S053 11/05/2015
THERMOCOOL SMART TOUCH UNI-DIRECTIONAL NAVIGATION ... BIOSENSE WEBSTER, INC. P040036 S054 04/25/2016
ThermoCool Smart Touch SF Catheters BIOSENSE WEBSTER, INC. P040036 S062 01/11/2018
THERMOCOOL SMART TOUCH BI-DIRECTIONAL CATHETERS BIOSENSE WEBSTER, INC. P040036 S049 03/19/2015
Thermocool Smart Touch Bi-Directional and Thermoco... BIOSENSE WEBSTER, INC. P040036 S069 02/26/2020
THERMOCOOL SMART TOUCH BI-DIRECTIONAL AND ELECTROP... BIOSENSE WEBSTER, INC. P040036 S057 09/21/2016
THERMOCOOL SF CATHETERS (BI-DIRECTIONAL), THERMOCO... BIOSENSE WEBSTER, INC. P030031 S047 09/20/2012
THERMOCOOL SF CATHETERS BIOSENSE WEBSTER, INC. P990071 S018 04/12/2013
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