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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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IntellaNav ST Boston Scientific Corp. P920047 S112 01/09/2019
IntellaTip MiFi Xp Ablation Catheters, IntellaNsv ... Boston Scientific Corp. P920047 S114 04/16/2019
Blazer II, Blazer II HTD, Blazer Prime HTD, Intell... Boston Scientific Corp. P920047 S115 05/03/2019
Blazer II XP, Blazer Prime HTD, Blazer Prime XP Ca... Boston Scientific Corp. P920047 S116 06/17/2019
Maestro 4000 Controller Firmware Boston Scientific Corp. P920047 S117 08/23/2019
Blazer II Cardiac Ablation Catheter and Cable Boston Scientific Corp. P920047 S118 11/07/2019
Medtronic RF Ablation Catheters MEDTRONIC Inc. P930029 S065 07/29/2019
Celsius RMT Catheter; Navistar RMT Thermocool Cath... Biosense Webster, Inc P950005 S071 03/08/2019
Celsius Catheter Biosense Webster, Inc P950005 S072 08/02/2019
Livewire TC Steerable Electrophysiology Catheter, ... St. Jude Medical P960016 S076 01/10/2019
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