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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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11 to 20 of 33 Results
productcode LPB PMA Number p Decision Date From 1/1/2020 Decision Date To 1/1/2021
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Device
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PMA
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nGEN Pump BIOSENSE WEBSTER, INC. P990071 S044 07/17/2020
SmartAblate Irrigation Tubing Set BIOSENSE WEBSTER, INC. P990071 S045 10/01/2020
IntellaNav ST Boston Scientific Corp. P920047 S119 01/27/2020
Blazer Prime HTD Boston Scientific Corp. P920047 S120 02/07/2020
IntellaNav ST Temperature Ablation Catheter Boston Scientific Corp. P920047 S121 02/19/2020
Blazer II Cardiac Ablation Catheter and Cable Boston Scientific Corp. P920047 S122 05/19/2020
Blazer Prime XP cardiac ablation catheters Boston Scientific Corp. P920047 S123 06/04/2020
Chilli II Cooled Ablation Catheter and Cable Boston Scientific Corp. P980003 S092 05/19/2020
Therapy Ablation Catheter, Therapy 4mm Thermistor ... IRVINE BIOMEDICAL, INC. P040014 S038 03/04/2020
Therapy Ablation Catheter (including Bi-Directiona... IRVINE BIOMEDICAL, INC. P040014 S039 04/24/2020
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