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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 01/19/2017
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Device
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PMA
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CELSIUS RMT AND NAVISTAR RMT CATHETERS Biosense Webster, Inc P950005 S025 08/10/2009
NAVISTAR RMT CATHETERS BIOSENSE WEBSTER, INC. P990025 S017 08/10/2009
NAVISTAR THERMOCOOL CATHETER BIOSENSE WEBSTER, INC. P030031 S014 08/12/2009
NAVISTAR AND CELSIUS THERMOCOOL CATHETERS BIOSENSE WEBSTER, INC. P030031 S020 11/24/2009
NAVISTAR RMT THERMOCOOL BIOSENSE WEBSTER, INC. P030031 S018 11/25/2009
NAVISTAR RMT THERMOCOOL BIOSENSE WEBSTER, INC. P040036 S013 11/25/2009
CELSIUS RMT Biosense Webster, Inc P950005 S028 11/25/2009
NAVISTAR RMT BIOSENSE WEBSTER, INC. P990025 S021 11/25/2009
NAVISTAR RMT THERMOCOOL CATHETER BIOSENSE WEBSTER, INC. P030031 S019 12/07/2009
EZ STEER NAV AND EZ STEER NAV DS CATHETERS BIOSENSE WEBSTER, INC. P030031 S021 12/14/2009
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