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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™ (PED2), Pipeline™ Vantage Embolization Device with Shield Tec
Generic NameIntracranial aneurysm flow diverter
ApplicantMicro Therapeutics, Inc. d/b/a ev3 Neurovascular
9775 Toledo Way
Irvine, CA 92618
PMA NumberP100018
Supplement NumberS044
Date Received01/26/2024
Decision Date04/25/2024
Product Code OUT 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for labeling changes [Directions for Use and Magnetic Resonance Imaging (MRI) Card] to the Pipeline Flex Embolization Device with Shield Technology and Pipeline Vantage Embolization Device with Shield Technology to incorporate more comprehensive MRI safety information
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