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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 30 Results
productcode LPB PMA Number p Decision Date From 1/1/2019 Decision Date To 1/1/2020
 
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Freezor Cardiac Cryoablation System Medtronic CryoCath LP P020045 S090 10/09/2019
Therapy Ablation Catheters IRVINE BIOMEDICAL, INC. P040014 S035 01/10/2019
Electrophysiology Cable, Therapy Ablation Catheter IRVINE BIOMEDICAL, INC. P040014 S036 04/11/2019
Therapy Ablation , Therapy 4mm Thermistor Ablation... IRVINE BIOMEDICAL, INC. P040014 S037 08/28/2019
ThermoCool SmartTouch SF Bi-Directional Navigation... BIOSENSE WEBSTER, INC. P040036 S064 03/26/2019
ThermoCool SmartTouch SF Catheter BIOSENSE WEBSTER, INC. P040036 S065 04/29/2019
Navistar RMT Thermocool Catheter BIOSENSE WEBSTER, INC. P040036 S066 03/08/2019
ThermoCool SmartTouch Uni-directional and ThermoCo... BIOSENSE WEBSTER, INC. P040036 S067 04/19/2019
EZ Steer Thermocool NAV Catheter and Navistar Ther... BIOSENSE WEBSTER, INC. P040036 S068 08/02/2019
Maestro 4000 Controller Boston Scientific Corp. P920047 S110 01/28/2019
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