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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 08/21/2014
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THERMOCOOL SMART TOUCH BI-DIRECTIONAL CATHETERS BIOSENSE WEBSTER, INC. P040036 S049 03/19/2015
EZ STEER THERMOCOOL NAV BIOSENSE WEBSTER, INC. P040036 S050 03/23/2015
THERMOCOOK SMARTTOUCH UNI-DIRECTIONAL NAVIGATION C... BIOSENSE WEBSTER, INC. P040036 S051 08/06/2015
THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CA... BIOSENSE WEBSTER, INC. P040036 S052 08/18/2015
THERMOCOOL SMARTTOUCH BIOSENSE WEBSTER, INC. P040036 S053 11/05/2015
THERMOCOOL SMART TOUCH UNI-DIRECTIONAL NAVIGATION ... BIOSENSE WEBSTER, INC. P040036 S054 04/25/2016
NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATIO... BIOSENSE WEBSTER, INC. P040036 S055 08/10/2017
THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CA... BIOSENSE WEBSTER, INC. P040036 S056 07/18/2016
THERMOCOOL SMART TOUCH BI-DIRECTIONAL AND ELECTROP... BIOSENSE WEBSTER, INC. P040036 S057 09/21/2016
Navistar Thermocool Deflectable Diagnostics/Ablati... BIOSENSE WEBSTER, INC. P040036 S058 10/24/2017
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