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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
Classification Nameintracranial aneurysm flow diverter
Generic Nameintracranial aneurysm flow diverter
Applicant
MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR
9775 toledo way
irvine, CA 92618
PMA NumberP100018
Supplement NumberS015
Date Received06/28/2017
Decision Date12/14/2018
Product Code
OUT[ Registered Establishments with OUT ]
Docket Number 18M-4779
Notice Date 01/25/2019
Advisory Committee Neurology
Clinical Trials NCT02186561
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the Pipeline Flex Embolization Device to expand the indications for use to include use in the internal carotid artery up to the terminus for the endovascular treatment of adults (22 years of age or older) with small and medium wide-necked (neck width >= 4 mm or dome-to-neck ratio < 2) saccular or fusiform intracranial aneurysms arising from a parent vessel with a diameter >= 2.0 mm and <= 5.0 mm.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
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