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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 50 Results
productcode OAD PMA Number p Decision Date From 1/1/2021 Decision Date To 1/1/2022
 
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PMA
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VISITAG SURPOINT External Processing Unit (EPU) BIOSENSE WEBSTER, INC. P030031 S110 11/12/2021
THERMOCOOL SMARTTOUCH SF Catheter BIOSENSE WEBSTER, INC. P030031 S109 03/26/2021
THERMOCOOL SMARTTOUCH SF Catheter BIOSENSE WEBSTER, INC. P030031 S118 05/13/2021
Thermocool Smarttouch SF BIOSENSE WEBSTER, INC. P030031 S113 03/02/2021
ThermoCool SmartTouch Catheters BIOSENSE WEBSTER, INC. P030031 S111 01/22/2021
Thermocool SF NAV, Celsius Thermocool, EZ Steer Th... BIOSENSE WEBSTER, INC. P030031 S112 02/02/2021
Therapy Cool Path, Safire BLU, Safire BLU SP, and ... IRVINE BIOMEDICAL,INC.(IBI) P040042 S048 03/12/2021
Therapy Cool Path, Safire BLU, Safire BLU SP, and ... IRVINE BIOMEDICAL, INC. P060019 S050 03/12/2021
Therapy Cool Path Duo, Safire BLU Duo, Cool Path, ... Abbott Medical P110016 S073 03/12/2021
Therapy Cool Path Duo and Therapy Cool Flex Abbott Medical P110016 S074 03/24/2021
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