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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 22 Results
productcode LPB PMA Number p Decision Date From 1/1/2023 Decision Date To 1/1/2024
 
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Coaxial Umbilical Cable - single pack, Coaxial Umb... Medtronic CryoCath LP P020045 S107 12/15/2023
Blazer II Cardiac Ablation System and Cable Boston Scientific Corp. P920047 S134 12/12/2023
Chilli Cooled Rf Ablation System Boston Scientific Corp. P980003 S097 12/12/2023
Freezer, Freezer Xtra Medtronic CryoCath LP P020045 S106 11/29/2023
Ampere™ Generator, Ampere™ Remote Control, Ampere™... IRVINE BIOMEDICAL, INC. P040014 S048 11/29/2023
Ampere™ Generator, Ampere™ Remote Control, Ampere™... St. Jude Medical P960016 S090 11/29/2023
Livewire™ TC XLS™ Ablation Catheter, Livewire™ TC ... St. Jude Medical P960016 S091 10/26/2023
Thermocool Smarttouch BIOSENSE WEBSTER, INC. P040036 S096 09/28/2023
THERMOCOOL SMARTTOUCH® SF BIOSENSE WEBSTER, INC. P040036 S091 08/03/2023
Blazer II Cardiac Ablation System and Cable Boston Scientific Corp. P920047 S132 07/27/2023
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