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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
Generic Nameintracranial aneurysm flow diverter
Applicant
Micro Therapeutics, Inc. d/b/a ev3 NEUROVASCULAR
9775 toledo way
irvine, CA 92618
PMA NumberP100018
Supplement NumberS024
Date Received03/10/2020
Decision Date10/05/2020
Product Code OUT 
Advisory Committee Neurology
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - pas
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling changes to incorporate completed results from the post-approval study (PAS) titled Prospective Study on Embolization of Intracranial Aneurysms with Pipeline Embolization Device (PREMIER).
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