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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 04/18/2015
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ThermoCool SmartTouch SF Catheter BIOSENSE WEBSTER, INC. P040036 S065 04/29/2019
SmartAblate Irrigation Pump, nGEN Pump Devices BIOSENSE WEBSTER, INC. P990071 S042 04/29/2019
ThermoCool SmartTouch Uni-directional and ThermoCo... BIOSENSE WEBSTER, INC. P040036 S067 04/19/2019
ThermoCool SmartTouch SF Bi-Directional Navigation... BIOSENSE WEBSTER, INC. P040036 S064 03/26/2019
Navistar RMT Thermocool Catheter BIOSENSE WEBSTER, INC. P040036 S066 03/08/2019
Celsius RMT Catheter; Navistar RMT Thermocool Cath... Biosense Webster, Inc P950005 S071 03/08/2019
nGEN Pump BIOSENSE WEBSTER, INC. P990071 S037 09/04/2018
Webster Electrophysiology Catheter, Celsius Electr... Biosense Webster, Inc P950005 S070 07/30/2018
Smartablate Cable BIOSENSE WEBSTER, INC. P990071 S041 07/30/2018
ThermoCool SmartTouch Uni-Bi-Directional Navigatio... BIOSENSE WEBSTER, INC. P040036 S063 07/26/2018
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