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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™ (Pipeline™ Shield); Pipeline™ Vantage Embolization Device wit
Generic NameIntracranial aneurysm flow diverter
ApplicantMicro Therapeutics, Inc. d/b/a ev3 Neurovascular
9775 Toledo Way
Irvine, CA 92618
PMA NumberP100018
Supplement NumberS054
Date Received05/28/2026
Decision Date06/26/2026
Product Code OUT 
Advisory Committee Neurology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval to remove the X-ray Photelectron Spectroscopy (XPS) testing and its associated Statistical Process Control (SPC) recording for the application of Shield Technology to the Pipeline braid and additional enhanced process controls, including minimum fill height verification and the addition of a 9 mm guard band
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