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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 09/01/2014
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SmartAblate System Foot Pedal. BIOSENSE WEBSTER, INC. P990071 S036 08/23/2017
NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATIO... BIOSENSE WEBSTER, INC. P040036 S055 08/10/2017
WEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETER Biosense Webster, Inc P950005 S061 08/10/2017
BIOSENSE WEBSTER CABLES BIOSENSE WEBSTER, INC. P990071 S034 08/10/2017
EZ Steer Smart Touch; Thermocooll ST Uni BIOSENSE WEBSTER, INC. P040036 S059 07/27/2017
Therapeutic Catheters Biosense Webster, Inc P950005 S065 07/27/2017
EZ Steer Non- Navigational 8mm (DS) ; EZ Steer DS ... Biosense Webster, Inc P950005 S066 07/27/2017
WEBSTER CATHETER; CELSIUS THERMOCOOL CATHETER; CEL... Biosense Webster, Inc P950005 S063 07/17/2017
Stockert 70 RF Generator Foot Pedal BIOSENSE WEBSTER, INC. P990071 S035 06/21/2017
THERMOCOOL SMART TOUCH BI-DIRECTIONAL AND ELECTROP... BIOSENSE WEBSTER, INC. P040036 S057 09/21/2016
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