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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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SmartAblate Irrigation Tubing Set BIOSENSE WEBSTER, INC. P990071 S059 02/19/2024
SmartAblate™ Irrigation Tubing Set (SAT001) BIOSENSE WEBSTER, INC. P990071 S058 02/16/2024
Thermocool Smarttouch BIOSENSE WEBSTER, INC. P040036 S096 09/28/2023
THERMOCOOL SMARTTOUCH® SF BIOSENSE WEBSTER, INC. P040036 S091 08/03/2023
EZ Steer ThermoCool Nav Catheter, EZ Steer ThermoC... BIOSENSE WEBSTER, INC. P040036 S095 06/12/2023
Deflectable Diagnostic/Ablation Catheter, EZ Steer... Biosense Webster, Inc P950005 S086 06/12/2023
Interface Cables BIOSENSE WEBSTER, INC. P990071 S057 06/12/2023
Thermocool Smarttouch BIOSENSE WEBSTER, INC. P040036 S094 05/03/2023
Thermocool Smarttouch Bi-directional Catheter, The... BIOSENSE WEBSTER, INC. P040036 S093 03/10/2023
SmartAblate™ Irrigation Tubing Set BIOSENSE WEBSTER, INC. P990071 S055 01/24/2023
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