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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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CELSIUS RMT THERMOCOOL MAGNETIC CATHETER BIOSENSE WEBSTER, INC. P040036 S027 12/12/2011
NAVISTAR RMT THERMOCOOL MAGNETIC STEERING CATHETER... BIOSENSE WEBSTER, INC. P030031 S037 12/23/2011
CELSIUS RMT THERMOCOOL MAGNETIC CATHETER BIOSENSE WEBSTER, INC. P040036 S028 12/23/2011
CELSIUS/CELSIUS RMT/EZ STEER/EZ STEER DS/NON-TEMPE... Biosense Webster, Inc P950005 S036 12/23/2011
NAVISTAR RMT THERMOCOOL CATHETER BIOSENSE WEBSTER, INC. P030031 S033 01/13/2012
NAVISTAR RMT THERMOCOOL CATHETER BIOSENSE WEBSTER, INC. P040036 S024 01/13/2012
CELSIUS/CELSIUS II DIAGNOSTIC/ABLATION DEFLECTABLE... Biosense Webster, Inc P950005 S033 02/08/2012
EZ STEER THERMOCOOL NAV CATHETER, NAVI-STAR ELEC... BIOSENSE WEBSTER, INC. P030031 S040 03/30/2012
EZ STEER THERMOCOOL NAV CATHETER, NAVI-STAR ELEC... BIOSENSE WEBSTER, INC. P040036 S029 03/30/2012
EZ STEER NAV ELECTROPHYSIOLOGY CATHETER BIOSENSE WEBSTER, INC. P990025 S030 03/30/2012
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