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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 08/26/2016
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CELSIUS/DEFLECTABLE TIP ELECTROPHYSIOLOGY CATHETER Biosense Webster, Inc P950005 S062 09/21/2016
THERMOCOOL SMARTTOUCH SF UNI-DIRECTIONAL NAVIGATIO... BIOSENSE WEBSTER, INC. P030031 S072 08/11/2016
SMARTABLATE SYSTEM: SMARTABLATE RF GENERATOR AND R... BIOSENSE WEBSTER, INC. P990071 S033 08/04/2016
THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CA... BIOSENSE WEBSTER, INC. P040036 S056 07/18/2016
THERMOCOOL SMART TOUCH UNI-DIRECTIONAL NAVIGATION ... BIOSENSE WEBSTER, INC. P040036 S054 04/25/2016
EZ Steer DS Bi-Directional Catheter,EZ Steer Bi-Di... Biosense Webster, Inc P950005 S060 04/25/2016
CELSIUS RMT THERMOCCOL CAT, CELSIUS THERMOCCOL CAT... BIOSENSE WEBSTER, INC. P030031 S059 12/17/2015
EZ STEER THERMOCOOL CATH, EZ STEER THERMOCOOL NAV ... BIOSENSE WEBSTER, INC. P040036 S044 12/17/2015
BIOSENSE WEBSTER CABLES, CELSIUS CATHETER, CELSIUS... Biosense Webster, Inc P950005 S051 12/17/2015
BIOSENSE WEBSTER CABLES, EZ STEER NAV CATHETER, NA... BIOSENSE WEBSTER, INC. P990025 S040 12/17/2015
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