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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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Celsius Catheter Biosense Webster, Inc P950005 S072 08/02/2019
Celsius RMT Catheter; Navistar RMT Thermocool Cath... Biosense Webster, Inc P950005 S071 03/08/2019
Webster Electrophysiology Catheter, Celsius Electr... Biosense Webster, Inc P950005 S070 07/30/2018
WEBSTER Catheter / CELSIUS Catheter Biosense Webster, Inc P950005 S069 03/28/2018
Webster Diag./Ablation Deflectable Tip Catheter Biosense Webster, Inc P950005 S068 10/17/2017
WEBSTER CATHETER, CELSIUS THERMOCOOL Catheter, CEL... Biosense Webster, Inc P950005 S067 10/10/2017
EZ Steer Non- Navigational 8mm (DS) ; EZ Steer DS ... Biosense Webster, Inc P950005 S066 07/27/2017
Therapeutic Catheters Biosense Webster, Inc P950005 S065 07/27/2017
Webster Diag/ Ablation Deflectable Tip Catheter Biosense Webster, Inc P950005 S064 10/24/2017
WEBSTER CATHETER; CELSIUS THERMOCOOL CATHETER; CEL... Biosense Webster, Inc P950005 S063 07/17/2017
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