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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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21 to 30 of 30 Results
productcode LPB PMA Number p Decision Date From 1/1/2019 Decision Date To 1/1/2020
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PMA
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Electrophysiology Cable, Therapy Ablation Catheter IRVINE BIOMEDICAL, INC. P040014 S036 04/11/2019
ThermoCool SmartTouch SF Bi-Directional Navigation... BIOSENSE WEBSTER, INC. P040036 S064 03/26/2019
Navistar RMT Thermocool Catheter BIOSENSE WEBSTER, INC. P040036 S066 03/08/2019
Celsius RMT Catheter; Navistar RMT Thermocool Cath... Biosense Webster, Inc P950005 S071 03/08/2019
Livewire TC Cables; Safire Ablation Catheter; Safi... St. Jude Medical P960016 S077 03/05/2019
Maestro 4000 Controller Boston Scientific Corp. P920047 S110 01/28/2019
Maestro 4000 Controller Boston Scientific Corp. P980003 S087 01/28/2019
Therapy Ablation Catheters IRVINE BIOMEDICAL, INC. P040014 S035 01/10/2019
Livewire TC Steerable Electrophysiology Catheter, ... St. Jude Medical P960016 S076 01/10/2019
IntellaNav ST Boston Scientific Corp. P920047 S112 01/09/2019
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