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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 DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHET... Biosense Webster, Inc P950005 S037 03/07/2013
CELSIUS DS Biosense Webster, Inc P950005 S059 11/05/2015
CELSIUS DS, NAVISTAR DS, EZ STEER DS and CELSIUS F... Biosense Webster, Inc P950005 S080 09/22/2021
CELSIUS ELECTROPHYSIOLOGY CATHETER Biosense Webster, Inc P950005 S055 12/08/2014
CELSIUS ELECTROPHYSIOLOGY CATHETER Biosense Webster, Inc P950005 S053 10/21/2014
Celsius Electrophysiology Catheter, Deflectable Ti... Biosense Webster, Inc P950005 S073 02/26/2020
Celsius FLTR (Flutter) Catheter, Celsius Electroph... Biosense Webster, Inc P950005 S081 07/09/2021
CELSIUS FLTR UNI -DIRECTIONAL CATHETER Biosense Webster, Inc P950005 S058 08/18/2015
CELSIUS FLTR UNI-DIRECTIONAL CATHETER Biosense Webster, Inc P950005 S052 09/12/2014
CELSIUS FLUTTERS, CELSIUS, CELSIUS RMT, EZ STEER 4... Biosense Webster, Inc P950005 S054 11/18/2014
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