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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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11 to 20 of 39 Results
productcode LPB PMA Number p Decision Date From 1/1/2021 Decision Date To 1/1/2022
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Therapy and Therapy Dual-8 IRVINE BIOMEDICAL, INC. P040014 S043 03/24/2021
Therapy Ablation Catheter, Therapy 4MM Thermistor ... IRVINE BIOMEDICAL, INC. P040014 S044 05/04/2021
Ampere™ Generator IRVINE BIOMEDICAL, INC. P040014 S045 10/14/2021
IntellaNav ST Ablation Catheter, Blazer II Tempera... Boston Scientific Corp. P920047 S124 08/05/2021
IntellaNav ST Boston Scientific Corp. P920047 S125 09/07/2021
EZ Steer ThermoCool Nav Deflectable Diagnostic/Ab... BIOSENSE WEBSTER, INC. P040036 S070 01/28/2021
ThermoCool SmartTouch SF Catheters BIOSENSE WEBSTER, INC. P040036 S076 01/22/2021
EZ Steer Thermocool, EZ Steer Thermocool Bi-Direct... BIOSENSE WEBSTER, INC. P040036 S077 02/02/2021
Thermocool Smarttouch BIOSENSE WEBSTER, INC. P040036 S078 03/02/2021
Navistar Thermocool, EZ Steer Thermocool Nav Bi- D... BIOSENSE WEBSTER, INC. P040036 S079 04/07/2021
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