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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 01/27/2015
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CATHETER, PERCUTANEOUS, CARDIAC ABLATION CELSIUS ... BIOSENSE WEBSTER, INC. P030031 S068 06/02/2015
CATHETER, PERCUTANEOUS, CARDIAC ABLATION CELSIUS E... Biosense Webster, Inc P950005 S057 06/02/2015
CATHETER, PERCUTANEOUS, CARDIAC ABLATION NAVISTAR ... BIOSENSE WEBSTER, INC. P990025 S046 06/02/2015
CELCIUS CATHETER,CELCIUS RMT CATHETER,EZ STEER CAT... Biosense Webster, Inc P950005 S043 04/25/2013
CELCIUS THERMOCOOL CATHETER, CELCIUS RMT THERMOCOO... BIOSENSE WEBSTER, INC. P030031 S051 04/25/2013
CELCIUS THERMOCOOL CATHETER,CELCIUS RMT THERMOCOOL... BIOSENSE WEBSTER, INC. P030031 S055 09/05/2013
CELCIUS/ RMT THERMOCOOL ,NAVISTAR THERMOCOOL ,NAVI... BIOSENSE WEBSTER, INC. P030031 S058 01/24/2014
CELSIUS Biosense Webster, Inc P950005 S082 03/08/2022
CELSIUS Biosense Webster, Inc P950005 S084 09/09/2022
CELSIUS & EZ STEER FAMILIES OF CATHETERS Biosense Webster, Inc P950005 S023 10/29/2007
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