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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Applicant BOSTON SCIENTIFIC productcode OAD
 
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PMA
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BLAZER™ Solid-Tip Ablation Catheter Cable 10’, BLA... Boston Scientific Corp. P020025 S139 04/05/2024
BLAZER™ OI Catheter Cable, INTELLATIP MIFI™ OI Cab... Boston Scientific Corp. P150005 S077 04/05/2024
Blazer and IntellaNav/MiFi Open-Irrigated Ablation... Boston Scientific Corp. P150005 S083 03/25/2024
Metriq Tubing Set and Metriq Footswitch Boston Scientific Corp. P150005 S082 03/12/2024
INTELLANAV STABLEPOINT™ Ablation Catheter & Force ... Boston Scientific Corp. P150005 S074 02/26/2024
IntellaNav™ XP and IntellaNav MiFi™ XP Ablation Ca... BOSTON SCIENTIFIC P020025 S143 02/16/2024
INTELLANAV MIFI™ Open-Irrigated Ablation Catheters Boston Scientific Corp. P150005 S081 02/16/2024
Blazer II XP Cardiac Ablation Catheter and Cable BOSTON SCIENTIFIC P020025 S142 12/12/2023
Blazer Open-Irrigated Ablation Catheter Boston Scientific Corp. P150005 S080 12/12/2023
Blazer II XP Cardiac Ablation Catheter and Cable BOSTON SCIENTIFIC P020025 S140 07/27/2023
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