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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.
 
DeviceFlow Re-Direction Endoluminal Device (FRED) and FRED X System
Generic NameIntracranial aneurysm flow diverter
ApplicantMicroVention, Inc.
35 Enterpricse
Aliso Viejo, CA 92656
PMA NumberP180027
Supplement NumberS006
Date Received11/23/2021
Decision Date02/15/2022
Product Code OUT 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a design change to the introducer sheath from a single-ended taper to a double-ended taper for the FRED System and FRED X System 3.5 to 5.5 mm stents.
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