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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 08/21/2014
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PMA
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CELSIUS RMT THERMOCOOL MAGNETIC CATHETER BIOSENSE WEBSTER, INC. P040036 S027 12/12/2011
CELSIUS RMT THERMOCOOL MAGNETIC CATHETER BIOSENSE WEBSTER, INC. P040036 S028 12/23/2011
EZ STEER THERMOCOOL NAV CATHETER, NAVI-STAR ELEC... BIOSENSE WEBSTER, INC. P040036 S029 03/30/2012
NAVISTAR®THERMOCOOL® DIAGNOSTIC/ABLATION CATHETER BIOSENSE WEBSTER, INC. P040036 S030 03/07/2013
NAVISTAR THERMOCOOL, NAVISTAR RMT THERMOCOOL, EZ S... BIOSENSE WEBSTER, INC. P040036 S031 04/12/2013
NAVISTAR RMT THERMOCOOL CATHETER BIOSENSE WEBSTER, INC. P040036 S032 07/01/2014
NAVISTAR THERMOCOOL CATHETER, NAVISTAR RMT THERMOC... BIOSENSE WEBSTER, INC. P040036 S033 07/22/2013
NAVISTAR THERMOCOOL CATHETER,NAVISTAR RMT THERMOCO... BIOSENSE WEBSTER, INC. P040036 S035 04/25/2013
7.5 FR NAVI-STAR THERMO-COOL VATHETER WITH THERMIS... BIOSENSE WEBSTER, INC. P040036 S036 05/29/2013
THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CA... BIOSENSE WEBSTER, INC. P040036 S037 02/11/2014
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