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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 10/22/2014
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PMA
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CELSIUS/DEFLECTABLE TIP ELECTROPHYSIOLOGY CATHETER Biosense Webster, Inc P950005 S062 09/21/2016
WEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETER Biosense Webster, Inc P950005 S061 08/10/2017
EZ Steer DS Bi-Directional Catheter,EZ Steer Bi-Di... Biosense Webster, Inc P950005 S060 04/25/2016
CELSIUS DS Biosense Webster, Inc P950005 S059 11/05/2015
CELSIUS FLTR UNI -DIRECTIONAL CATHETER Biosense Webster, Inc P950005 S058 08/18/2015
CATHETER, PERCUTANEOUS, CARDIAC ABLATION CELSIUS E... Biosense Webster, Inc P950005 S057 06/02/2015
EZ STEER DS BI-DIRECTIONAL CATHETER, CELSIUS CATHE... Biosense Webster, Inc P950005 S056 03/19/2015
CELSIUS ELECTROPHYSIOLOGY CATHETER Biosense Webster, Inc P950005 S055 12/08/2014
CELSIUS FLUTTERS, CELSIUS, CELSIUS RMT, EZ STEER 4... Biosense Webster, Inc P950005 S054 11/18/2014
CELSIUS ELECTROPHYSIOLOGY CATHETER Biosense Webster, Inc P950005 S053 10/21/2014
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