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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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PMA
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IntellaNav MiFi Open-Irrigated (OI) and IntellaTip... Boston Scientific Corp. P150005 S056 06/04/2020
IntellaNav MiFi Open-Irrigated (OI) Ablation Cathe... Boston Scientific Corp. P150005 S076 07/17/2023
INTELLA TIP MIFI XP TEMPERATURE ABLATION CATHETERS BOSTON SCIENTIFIC P020025 S066 01/15/2015
Intella Tip MiFi XP cardiac ablation catheters BOSTON SCIENTIFIC P020025 S098 06/01/2017
INTELLA TIP MIFI XP ABLATION CATHETER BOSTON SCIENTIFIC P020025 S050 12/03/2013
EPT-1000XP CARDIAC ABLATION SYSTEM BOSTON SCIENTIFIC P020025 S007 10/12/2004
EPT-1000XP CARDIAC ABLATION SYSTEM BOSTON SCIENTIFIC P020025 S078 09/15/2015
EPT-1000XP CARDIAC ABLATION SYSTEM BOSTON SCIENTIFIC P020025 S044 10/07/2013
EPT-1000 XP RF ABLATION SYSTEMS BOSTON SCIENTIFIC P020025 S003 01/07/2004
EPT-1000 XP RF ABLATION SYSTEM BOSTON SCIENTIFIC P020025 S038 02/22/2013
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