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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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11 to 20 of 50 Results
productcode OAD PMA Number p Decision Date From 1/1/2021 Decision Date To 1/1/2022
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PMA
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IntellaNav MiFi XP, IntellaNav XP BOSTON SCIENTIFIC P020025 S133 09/07/2021
IntellaNav Open Irrigated Ablation Catheters, Inte... Boston Scientific Corp. P150005 S067 09/07/2021
IntellaTip MiFi Filter Module, IntellaTip MiFi Ref... BOSTON SCIENTIFIC P020025 S132 08/17/2021
Blazer Open Irrigated Ablation Catheter Boston Scientific Corp. P150005 S066 08/06/2021
Blazer II XP Temperature Ablation Catheter, Blazer... BOSTON SCIENTIFIC P020025 S129 08/05/2021
Blazer Open-Irrigated Ablation Catheter, IntellaNa... Boston Scientific Corp. P150005 S061 08/05/2021
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
Celsius FLTR (Flutter) Catheter, EZ STEER NAV Bi-D... BIOSENSE WEBSTER, INC. P010068 S066 07/09/2021
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