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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name artificial chordae tendineae surgical replacement system
De Novo Number DEN230069
Device Name Mi-CHORD System
Requester
lsi solutions, inc.
7796 victor-mendon rd.
victor,  NY  14564
Contact christopher b. miller
Regulation Number870.3490
Classification Product Code
SBK  
Date Received09/29/2023
Decision Date 06/11/2024
Decision granted (DENG)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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