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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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11 to 20 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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Medtronic RF Ablation Catheters MEDTRONIC Inc. P930029 S065 07/29/2019
Blazer II XP, Blazer Prime HTD, Blazer Prime XP Ca... Boston Scientific Corp. P920047 S116 06/17/2019
CoolFlow Irrigation Tubing Set BIOSENSE WEBSTER, INC. P990071 S040 05/08/2019
Livewire TC Ablation Catheter (Livewire TC) St. Jude Medical P960016 S078 05/07/2019
Blazer II, Blazer II HTD, Blazer Prime HTD, Intell... Boston Scientific Corp. P920047 S115 05/03/2019
Chilli II Boston Scientific Corp. P980003 S089 05/03/2019
ThermoCool SmartTouch SF Catheter BIOSENSE WEBSTER, INC. P040036 S065 04/29/2019
SmartAblate Irrigation Pump, nGEN Pump Devices BIOSENSE WEBSTER, INC. P990071 S042 04/29/2019
ThermoCool SmartTouch Uni-directional and ThermoCo... BIOSENSE WEBSTER, INC. P040036 S067 04/19/2019
IntellaTip MiFi Xp Ablation Catheters, IntellaNsv ... Boston Scientific Corp. P920047 S114 04/16/2019
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