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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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PMA
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CELSIUS DS Biosense Webster, Inc P950005 S059 11/05/2015
EZ Steer DS Bi-Directional Catheter,EZ Steer Bi-Di... Biosense Webster, Inc P950005 S060 04/25/2016
WEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETER Biosense Webster, Inc P950005 S061 08/10/2017
CELSIUS/DEFLECTABLE TIP ELECTROPHYSIOLOGY CATHETER Biosense Webster, Inc P950005 S062 09/21/2016
WEBSTER CATHETER; CELSIUS THERMOCOOL CATHETER; CEL... Biosense Webster, Inc P950005 S063 07/17/2017
Webster Diag/ Ablation Deflectable Tip Catheter Biosense Webster, Inc P950005 S064 10/24/2017
Therapeutic Catheters Biosense Webster, Inc P950005 S065 07/27/2017
EZ Steer Non- Navigational 8mm (DS) ; EZ Steer DS ... Biosense Webster, Inc P950005 S066 07/27/2017
WEBSTER CATHETER, CELSIUS THERMOCOOL Catheter, CEL... Biosense Webster, Inc P950005 S067 10/10/2017
Webster Diag./Ablation Deflectable Tip Catheter Biosense Webster, Inc P950005 S068 10/17/2017
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