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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceFRED X System
Generic NameIntracranial aneurysm flow diverter
ApplicantMicroVention, Inc.
35 Enterpricse
Aliso Viejo, CA 92656
PMA NumberP180027
Supplement NumberS005
Date Received11/16/2021
Decision Date04/26/2022
Product Code OUT 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the revised protocol for the post-approval study (PAS).
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