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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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CELSIUS/RMT/EZ STEER/EZ STEER DS/NON-TEMPERATURE S... Biosense Webster, Inc P950005 S034 04/06/2011
NAVISTAR/RMT/EZ STEER NAV/QWIKSTAR/INTERFACE CABLE... BIOSENSE WEBSTER, INC. P990025 S028 04/06/2011
INTERFACE CABLES BIOSENSE WEBSTER, INC. P990071 S012 04/06/2011
NAVISTAR THERMOCOOL CATHETER FOR RADIOFREQUENCY AB... BIOSENSE WEBSTER, INC. P030031 S031 09/23/2011
CELSIUS THERMOCOOL/CELSIUS RMT THERMOCOOL/NAVISTAR... BIOSENSE WEBSTER, INC. P030031 S035 10/07/2011
NAVISTAR/NAVISTAR RMT THERMOCOOL/EZ STEER THERMOCO... BIOSENSE WEBSTER, INC. P040036 S026 10/07/2011
CELSIUS/CELSIUS RMT/EZ STEER/EZ STEER DS/NON-TEMPE... Biosense Webster, Inc P950005 S035 10/07/2011
NAVISTAR/NAVISTAR RMT/EZ STEER NAV/QWIKSTAR CATHET... BIOSENSE WEBSTER, INC. P990025 S029 10/07/2011
INTERFACE CABLES BIOSENSE WEBSTER, INC. P990071 S015 10/07/2011
NAVISTAR RMT THERMOCOOL MAGNETIC STEERING CATHETER... BIOSENSE WEBSTER, INC. P030031 S036 12/12/2011
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