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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.
 
DevicePipeline Flex Embolization Device with Shield Technology
Generic NameIntracranial aneurysm flow diverter
ApplicantMicro Therapeutics, Inc. d/b/a ev3 Neurovascular
9775 Toledo Way
Irvine, CA 92618
PMA NumberP100018
Supplement NumberS026
Date Received05/26/2020
Decision Date04/13/2021
Product Code OUT 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for design changes to the Pipeline Flex Embolization Device to add a surface modification to the implant.
Post-Approval StudyShow Report Schedule and Study Progress
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