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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 07/29/2014
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NAVISTAR RMT THERMOCOOL CATHETER BIOSENSE WEBSTER, INC. P030031 S029 05/27/2010
CELSIUS RMT THERMOCOOL CATHETER BIOSENSE WEBSTER, INC. P040036 S022 05/27/2010
NAVISTAR RMT THERMOCOOL CATHETER BIOSENSE WEBSTER, INC. P030031 S024 06/28/2010
CELSIUS RMT THERMOCOOL CATHETER BIOSENSE WEBSTER, INC. P040036 S017 06/28/2010
EZ STEER THERMOCOOL NAV CATHETER BIOSENSE WEBSTER, INC. P030031 S022 07/07/2010
EZ STEER THERMOCOOL NAV CATHETER BIOSENSE WEBSTER, INC. P040036 S015 07/07/2010
CELSIUS THERMOCOOL CATHETER BIOSENSE WEBSTER, INC. P030031 S030 07/15/2010
CELSIUS THERMOCOOL & NAVISTAR THERMOCOOL BIOSENSE WEBSTER, INC. P030031 S028 10/01/2010
NAVISTAR THERMOCOOL BIOSENSE WEBSTER, INC. P040036 S021 10/01/2010
CELSIUS CATHETER, NON-TEMPERATURE SENSING ABLATION... Biosense Webster, Inc P950005 S030 10/01/2010
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