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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 39 Results
productcode LPB PMA Number p Decision Date From 1/1/2021 Decision Date To 1/1/2022
 
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PMA
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SmartAblate Irrigation Tubing Set BIOSENSE WEBSTER, INC. P990071 S047 12/23/2021
RF Conductr, RF Contactr, RF Enhancr II, RF Marinr... MEDTRONIC Inc. P930029 S070 12/07/2021
Ampere™ Generator IRVINE BIOMEDICAL, INC. P040014 S045 10/14/2021
Ampere™ Generator St. Jude Medical P960016 S088 10/14/2021
Freezor Cardiac Cryoablation System Medtronic CryoCath LP P020045 S095 10/12/2021
Stockert SMARTABLATE System BIOSENSE WEBSTER, INC. P990071 S046 09/23/2021
NAVISTAR THERMOCOOL, THERMOCOOL EZ STEER and THERM... BIOSENSE WEBSTER, INC. P040036 S082 09/22/2021
EZ Steer ThermoCool Catheter, EZ Steer ThermoCool ... BIOSENSE WEBSTER, INC. P040036 S086 09/22/2021
CELSIUS DS, NAVISTAR DS, EZ STEER DS and CELSIUS F... Biosense Webster, Inc P950005 S080 09/22/2021
Biosense Webster Cables, Celsius Catheter, Celsius... Biosense Webster, Inc P950005 S083 09/22/2021
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