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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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11 to 20 of 25 Results
productcode LPB PMA Number p Decision Date From 1/1/2022 Decision Date To 1/1/2023
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PMA
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SmartAblate Irrigation Tubing Set and nGEN Pump BIOSENSE WEBSTER, INC. P990071 S054 06/08/2022
Biosense Webster Cables BIOSENSE WEBSTER, INC. P990071 S056 09/30/2022
IntellaNav™ ST Ablation Catheter, Blazer™ II Tempe... Boston Scientific Corp. P920047 S126 02/22/2022
Blazer II Catheter, Blazer II HTD Catheter, Blazer... Boston Scientific Corp. P920047 S127 02/25/2022
INTELLANAV™ ST Ablation Catheter, BLAZER™ II Tempe... Boston Scientific Corp. P920047 S128 09/21/2022
Blazer II Cardiac Ablation System and Cable Boston Scientific Corp. P920047 S129 11/15/2022
Chilli II Cooled Catheter, Sterile Cables, Tubing ... Boston Scientific Corp. P980003 S093 02/25/2022
Chilli Cooled RF Ablation System Boston Scientific Corp. P980003 S094 11/15/2022
Therapy Ablation Catheter (4mm and 8mm), Electroph... IRVINE BIOMEDICAL, INC. P040014 S046 11/15/2022
Therapy Ablation Catheter (4mm and 8mm), Electroph... IRVINE BIOMEDICAL, INC. P040014 S047 12/16/2022
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