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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 NumberS016
Date Received09/14/2017
Decision Date10/11/2017
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 
Change to the hypotube manufacturing process of a sub tier supplier in order to improve overall component yield and reduce scrap.
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