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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 09/01/2014
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QUIKSTAR FAMILY OF CATHETERS BIOSENSE WEBSTER, INC. P990025 S014 10/29/2007
NAVISTAR 4 MM BI DIRECTIONAL DIAGNOSTIC/ABLATION C... BIOSENSE WEBSTER, INC. P990025 S013 08/23/2007
NAVISTAR 4 MM BI-DIRECTIONAL DIAGNOSTIC/ABLATION C... BIOSENSE WEBSTER, INC. P990025 S012 10/06/2006
QWIKSTAR NAVIGATION/ABLATION CATHETER BIOSENSE WEBSTER, INC. P990025 S011 03/28/2006
NAVISTAR DIAGNOSTIC ABLATION TIP CATHETER,QWIKSTAR... BIOSENSE WEBSTER, INC. P990025 S010 02/16/2006
NAVISTAR RMT DIAGNOSTIC/ABLATION STEERABLE TIP CAT... BIOSENSE WEBSTER, INC. P990025 S009 01/26/2006
Deflectable Diagnostic/Ablation Catheter, EZ Steer... Biosense Webster, Inc P950005 S086 06/12/2023
Celsius Catheter, Celsius RMT Catheter, Celsius FL... Biosense Webster, Inc P950005 S085 09/30/2022
CELSIUS Biosense Webster, Inc P950005 S084 09/09/2022
Biosense Webster Cables, Celsius Catheter, Celsius... Biosense Webster, Inc P950005 S083 09/22/2021
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