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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 06/30/2016
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CELSIUS CATHETER,CELSIUS RMT CATHETER,EZ STEER CAT... Biosense Webster, Inc P950005 S049 01/24/2014
CELSIUS CATHETER, CELSIUS RMT CATHETER Biosense Webster, Inc P950005 S050 07/02/2014
BIOSENSE WEBSTER CABLES, CELSIUS CATHETER, CELSIUS... Biosense Webster, Inc P950005 S051 12/17/2015
CELSIUS FLTR UNI-DIRECTIONAL CATHETER Biosense Webster, Inc P950005 S052 09/12/2014
CELSIUS ELECTROPHYSIOLOGY CATHETER Biosense Webster, Inc P950005 S053 10/21/2014
CELSIUS FLUTTERS, CELSIUS, CELSIUS RMT, EZ STEER 4... Biosense Webster, Inc P950005 S054 11/18/2014
CELSIUS ELECTROPHYSIOLOGY CATHETER Biosense Webster, Inc P950005 S055 12/08/2014
EZ STEER DS BI-DIRECTIONAL CATHETER, CELSIUS CATHE... Biosense Webster, Inc P950005 S056 03/19/2015
CATHETER, PERCUTANEOUS, CARDIAC ABLATION CELSIUS E... Biosense Webster, Inc P950005 S057 06/02/2015
CELSIUS FLTR UNI -DIRECTIONAL CATHETER Biosense Webster, Inc P950005 S058 08/18/2015
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