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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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11 to 20 of 220 Results
Applicant BOSTON SCIENTIFIC productcode OAD Decision Date To 04/28/2024
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Device
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PMA
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IntellaNav MiFi Open-Irrigated (OI) Ablation Cathe... Boston Scientific Corp. P150005 S076 07/17/2023
Blazer IITM XP Cardiac RF Ablation System (also br... BOSTON SCIENTIFIC P020025 S138 04/27/2023
Blazer Open Irrigated Cardiac Ablation System Boston Scientific Corp. P150005 S075 04/27/2023
Open-Irrigated Cardiac Ablation Catheters Boston Scientific Corp. P150005 S072 11/21/2022
Blazer II XP Cardiac Ablation Catheter and Cable BOSTON SCIENTIFIC P020025 S137 11/15/2022
Blazer Open-Irrigated Ablation Catheter Boston Scientific Corp. P150005 S073 11/15/2022
BLAZER ™ II XP Temperature Ablation Catheter, BLAZ... BOSTON SCIENTIFIC P020025 S136 09/21/2022
BLAZER™ OPEN-IRRIGATED Ablation Catheter, INTELANA... Boston Scientific Corp. P150005 S071 09/21/2022
Blazer II XP Catheter, Blazer Prime XP Catheter, I... BOSTON SCIENTIFIC P020025 S135 02/25/2022
Blazer Open Irrigated Catheter, IntellNav MiFi OI ... Boston Scientific Corp. P150005 S070 02/25/2022
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