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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 07/26/2016
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CELSIUS, CELSIUS RMT, EZ STEER, EZ STEER DS CATHET... Biosense Webster, Inc P950005 S038 04/12/2013
CELSIUS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHET... Biosense Webster, Inc P950005 S039 07/25/2012
CELSIUS CATHETERS Biosense Webster, Inc P950005 S040 10/24/2012
BI-DIRECTIONAL CELSIUS FLTR CATHETERS (D-1359-XX-S... Biosense Webster, Inc P950005 S041 06/06/2013
CELSIUS CATHETER, CELSIUS RMT CATHETER, EZ STEER D... Biosense Webster, Inc P950005 S042 07/22/2013
CELCIUS CATHETER,CELCIUS RMT CATHETER,EZ STEER CAT... Biosense Webster, Inc P950005 S043 04/25/2013
EZ STEER BI-DIRECTIONAL NON NAV 4 MM TIP WITH THER... Biosense Webster, Inc P950005 S044 05/29/2013
CELSIUS CATHETER,CELSIUS RMT CATHETER,EZ STEER CAT... Biosense Webster, Inc P950005 S045 09/05/2013
NAVISTAR THERMOCOOL, NAVISTAR RMT THERMOCOOL, EZ S... Biosense Webster, Inc P950005 S046 10/09/2013
BIOSENSE WEBSTER CELSIUS FLTR CATHETER Biosense Webster, Inc P950005 S048 11/26/2013
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