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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 NumberS020
Date Received04/26/2019
Decision Date05/22/2019
Product Code OUT 
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Upgrades to the laser equipment used to form the distal tip of the introducer sheath of the Pipeline Flex Embolization device.
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