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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 25 Results
productcode LPB PMA Number p Decision Date From 1/1/2022 Decision Date To 1/1/2023
 
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Therapy Ablation Catheter (4mm and 8mm), Electroph... IRVINE BIOMEDICAL, INC. P040014 S047 12/16/2022
FlexAbility™ Ablation Catheter, Sensor Enabled™ Abbott Medical P110016 S080 12/14/2022
Livewire TC Ablation Catheter St. Jude Medical P960016 S089 12/08/2022
Therapy Ablation Catheter (4mm and 8mm), Electroph... IRVINE BIOMEDICAL, INC. P040014 S046 11/15/2022
Blazer II Cardiac Ablation System and Cable Boston Scientific Corp. P920047 S129 11/15/2022
Chilli Cooled RF Ablation System Boston Scientific Corp. P980003 S094 11/15/2022
ThermoCool SmartTouch Catheters, NaviStar ThermoCo... BIOSENSE WEBSTER, INC. P040036 S090 09/30/2022
Celsius Catheter, Celsius RMT Catheter, Celsius FL... Biosense Webster, Inc P950005 S085 09/30/2022
Biosense Webster Cables BIOSENSE WEBSTER, INC. P990071 S056 09/30/2022
INTELLANAV™ ST Ablation Catheter, BLAZER™ II Tempe... Boston Scientific Corp. P920047 S128 09/21/2022
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