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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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11 to 20 of 300 Results
Applicant BIOSENSE WEBSTER, INC productcode LPB Center Devices Decision Date To 05/30/2016
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PMA
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ThermoCool SmartTouch Catheters, NaviStar ThermoCo... BIOSENSE WEBSTER, INC. P040036 S090 09/30/2022
Celsius Catheter, Celsius RMT Catheter, Celsius FL... Biosense Webster, Inc P950005 S085 09/30/2022
Biosense Webster Cables BIOSENSE WEBSTER, INC. P990071 S056 09/30/2022
NAVISTAR THERMOCOOL, THERMOCOOL SMARTTOUCH (ST) BIOSENSE WEBSTER, INC. P040036 S089 09/09/2022
CELSIUS Biosense Webster, Inc P950005 S084 09/09/2022
SmartAblate Irrigation Tubing Set and nGEN Pump BIOSENSE WEBSTER, INC. P990071 S054 06/08/2022
SmartAblate Irrigation Tubing Set BIOSENSE WEBSTER, INC. P990071 S053 03/15/2022
NAVISTAR THERMOCOOL, THERMOCOOL SMARTTOUCH BIOSENSE WEBSTER, INC. P040036 S084 03/08/2022
CELSIUS Biosense Webster, Inc P950005 S082 03/08/2022
nGEN Pump BIOSENSE WEBSTER, INC. P990071 S051 03/08/2022
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