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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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STOCKERT 70 RADIOFREQUENCY GENERATOR FOR CARDIAC A... BIOSENSE WEBSTER, INC. P990071 S020 11/20/2012
NAVISTAR® THERMOCOOL® DIAGNOSTIC/ABLATION CATHETER... BIOSENSE WEBSTER, INC. P030031 S041 03/07/2013
NAVISTAR®THERMOCOOL® DIAGNOSTIC/ABLATION CATHETER BIOSENSE WEBSTER, INC. P040036 S030 03/07/2013
CELSIUS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHET... Biosense Webster, Inc P950005 S037 03/07/2013
NAVISTAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHE... BIOSENSE WEBSTER, INC. P990025 S031 03/07/2013
STOCKERT 70 RADIOFREQUENCY GENERATOR BIOSENSE WEBSTER, INC. P990071 S017 03/07/2013
CELSIUS THERMOCOOL, CELSIUS RMT THERMOCOOL, NAVIST... BIOSENSE WEBSTER, INC. P030031 S042 04/12/2013
NAVISTAR THERMOCOOL, NAVISTAR RMT THERMOCOOL, EZ S... BIOSENSE WEBSTER, INC. P040036 S031 04/12/2013
CELSIUS, CELSIUS RMT, EZ STEER, EZ STEER DS CATHET... Biosense Webster, Inc P950005 S038 04/12/2013
NAVISTAR, NAVISTAR RMT, EZ STEER NAV CATHETERS BIOSENSE WEBSTER, INC. P990025 S032 04/12/2013
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