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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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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BLAZER II/BLAZER II XP CARDIAC ABLATION CATHETERS BOSTON SCIENTIFIC P020025 S011 06/17/2005
Blazer IITM XP Cardiac RF Ablation System (also br... BOSTON SCIENTIFIC P020025 S138 04/27/2023
BLAZER IIXP/BLAZER PRIME XP ABLATION CATHETERS AND... BOSTON SCIENTIFIC P020025 S048 10/23/2013
Blazer OI & IntellaNav OI Ablation Catheters Boston Scientific Corp. P150005 S012 12/06/2016
Blazer OI / IntellaNav OI / Intella Tip MiFi OI Boston Scientific Corp. P150005 S028 10/11/2017
Blazer OI and IntellaNav OI Boston Scientific Corp. P150005 S026 09/15/2017
Blazer OI Catheter, IntellaNav OI Catheter, Intell... Boston Scientific Corp. P150005 S059 12/11/2020
Blazer OI, IntellaNav OI, IntellaTip MiFi OI Boston Scientific Corp. P150005 S020 07/24/2017
Blazer OI, IntellaNav OI, IntellaTip MiFi OI Boston Scientific Corp. P150005 S027 09/26/2017
Blazer OI, IntellaNav OI, IntellaTip MiFi OI, and ... Boston Scientific Corp. P150005 S041 01/09/2019
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