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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 Center Devices Decision Date To 10/22/2016
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PMA
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EZ STEER THERMOCOOL NAV CATHETER BIOSENSE WEBSTER, INC. P040036 S015 07/07/2010
NAVISTAR THERMOCOOL CATHETER FAMILY BIOSENSE WEBSTER, INC. P040036 S016 03/03/2011
CELSIUS RMT THERMOCOOL CATHETER BIOSENSE WEBSTER, INC. P040036 S017 06/28/2010
NAVISTAR THERMOCOOL/NAVISTAR RMT THERMOCOOL/ EZ ST... BIOSENSE WEBSTER, INC. P040036 S019 03/04/2010
NAVISTAR THERMOCOOL BIOSENSE WEBSTER, INC. P040036 S020 03/12/2010
NAVISTAR THERMOCOOL BIOSENSE WEBSTER, INC. P040036 S021 10/01/2010
CELSIUS RMT THERMOCOOL CATHETER BIOSENSE WEBSTER, INC. P040036 S022 05/27/2010
NAVISTAR THERMOCOOL//NAVISTAR RMT//EZ STEER/EZ STE... BIOSENSE WEBSTER, INC. P040036 S023 04/06/2011
NAVISTAR RMT THERMOCOOL CATHETER BIOSENSE WEBSTER, INC. P040036 S024 01/13/2012
NAVISTAR/NAVISTAR RMT THERMOCOOL/EZ STEER THERMOCO... BIOSENSE WEBSTER, INC. P040036 S026 10/07/2011
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