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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 apical closure device
De Novo Number DEN150029
Device Name Permaseal
Requester
micro interventional devices, inc.
5 caufield pl. suite 102
newtown,  PA  18940
Contact linda morgan
Regulation Number870.4510
Classification Product Code
PNQ  
Date Received06/22/2015
Decision Date 07/27/2016
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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