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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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Biosense Webster Cables BIOSENSE WEBSTER, INC. P990071 S056 09/30/2022
SmartAblate Irrigation Tubing Set and nGEN Pump BIOSENSE WEBSTER, INC. P990071 S054 06/08/2022
SmartAblate Irrigation Tubing Set BIOSENSE WEBSTER, INC. P990071 S053 03/15/2022
nGEN Pump BIOSENSE WEBSTER, INC. P990071 S051 03/08/2022
Chilli Cooled RF Ablation System Boston Scientific Corp. P980003 S094 11/15/2022
Chilli II Cooled Catheter, Sterile Cables, Tubing ... Boston Scientific Corp. P980003 S093 02/25/2022
Livewire TC Ablation Catheter St. Jude Medical P960016 S089 12/08/2022
Celsius Catheter, Celsius RMT Catheter, Celsius FL... Biosense Webster, Inc P950005 S085 09/30/2022
CELSIUS Biosense Webster, Inc P950005 S084 09/09/2022
CELSIUS Biosense Webster, Inc P950005 S082 03/08/2022
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