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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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31 to 39 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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Therapy and Therapy Dual-8 IRVINE BIOMEDICAL, INC. P040014 S043 03/24/2021
7F Freezor Cardiac Cryoablation Catheter, 7F Freez... Medtronic CryoCath LP P020045 S094 03/17/2021
Therapy Ablation Catheters IRVINE BIOMEDICAL, INC. P040014 S042 03/12/2021
Livewire TC Steerable Electrophysiology Catheter, ... St. Jude Medical P960016 S086 03/12/2021
Thermocool Smarttouch BIOSENSE WEBSTER, INC. P040036 S078 03/02/2021
EZ Steer Thermocool, EZ Steer Thermocool Bi-Direct... BIOSENSE WEBSTER, INC. P040036 S077 02/02/2021
Celsius, Celsius Flutter, EZ Steer Biosense Webster, Inc P950005 S076 02/02/2021
EZ Steer ThermoCool Nav Deflectable Diagnostic/Ab... BIOSENSE WEBSTER, INC. P040036 S070 01/28/2021
ThermoCool SmartTouch SF Catheters BIOSENSE WEBSTER, INC. P040036 S076 01/22/2021
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