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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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NAVISTAR® THERMOCOOL® DIAGNOSTIC/ABLATION CATHETER... BIOSENSE WEBSTER, INC. P030031 S041 03/07/2013
CELSIUS THERMOCOOL, CELSIUS RMT THERMOCOOL, NAVIST... BIOSENSE WEBSTER, INC. P030031 S042 04/12/2013
CELSIUS THERMOCOOL CATHETER BIOSENSE WEBSTER, INC. P030031 S043 07/23/2012
NAVISTAR RMT THERMOCOOL, D-1266-XX, CELSIUS RMT TH... BIOSENSE WEBSTER, INC. P030031 S044 07/01/2014
THERMOCOOL SF CATHETERS (BI-DIRECTIONAL), THERMOCO... BIOSENSE WEBSTER, INC. P030031 S047 09/20/2012
CELSIUS THERMOCOOL CATHETERS BIOSENSE WEBSTER, INC. P030031 S048 10/24/2012
CELSIUS THERMOCOOL CATHETER, CELSIUS RMT THERMOCOO... BIOSENSE WEBSTER, INC. P030031 S050 07/22/2013
CELCIUS THERMOCOOL CATHETER, CELCIUS RMT THERMOCOO... BIOSENSE WEBSTER, INC. P030031 S051 04/25/2013
7F CELCIUS THERMO-COOL CATHETER WITH THERMOCOUPLEM... BIOSENSE WEBSTER, INC. P030031 S052 05/29/2013
THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CA... BIOSENSE WEBSTER, INC. P030031 S053 02/11/2014
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