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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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21 to 30 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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Freezor Xtra Cardiac Cryoablation Catheter Medtronic CryoCath LP P020045 S099 08/22/2021
Freezor, Freezor Xtra and Freezor MAX Cardiac Cryo... Medtronic CryoCath LP P020045 S097 09/10/2021
IntellaNav ST Boston Scientific Corp. P920047 S125 09/07/2021
IntellaNav ST Ablation Catheter, Blazer II Tempera... Boston Scientific Corp. P920047 S124 08/05/2021
LiveWire TC Ablation Catheter and Safire Ablation ... St. Jude Medical P960016 S087 05/18/2021
Livewire TC Steerable Electrophysiology Catheter, ... St. Jude Medical P960016 S086 03/12/2021
Navistar Thermocool, EZ Steer Thermocool Nav Bi- D... BIOSENSE WEBSTER, INC. P040036 S079 04/07/2021
NAVISTAR THERMOCOOL, THERMOCOOL EZ STEER and THERM... BIOSENSE WEBSTER, INC. P040036 S082 09/22/2021
RF Conductr, RF Contactr, RF Enhancr II, RF Marinr... MEDTRONIC Inc. P930029 S070 12/07/2021
SmartAblate Irrigation Tubing Set BIOSENSE WEBSTER, INC. P990071 S047 12/23/2021
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