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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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productcode OAD PMA Number p Decision Date From 1/1/2021 Decision Date To 1/1/2022
 
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Device
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PMA
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IntellaTip MiFi OI, IntellaNav MiFi OI, IntellaNav... Boston Scientific Corp. P150005 S068 12/10/2021
IntellaNav Open Irrigated Ablation Catheters, Inte... Boston Scientific Corp. P150005 S067 09/07/2021
Blazer Open Irrigated Ablation Catheter Boston Scientific Corp. P150005 S066 08/06/2021
MetriQ Irrigation Tubing Set Boston Scientific Corp. P150005 S065 07/21/2021
IntellaNav MiFi Open-Irrigated Ablation Catheters,... Boston Scientific Corp. P150005 S064 07/20/2021
Blazer Open-Irrigated Ablation Catheter Boston Scientific Corp. P150005 S063 07/14/2021
MetriQ Pump Boston Scientific Corp. P150005 S062 03/03/2021
Blazer Open-Irrigated Ablation Catheter, IntellaNa... Boston Scientific Corp. P150005 S061 08/05/2021
Ampere™ Generator Abbott Medical P110016 S079 10/14/2021
FlexAbility Ablation Catheter, FlexAbility Ablatio... Abbott Medical P110016 S078 09/22/2021
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