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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NamePIPELINE EMBOLIZATION DEVICE
Classification Nameintracranial aneurysm flow diverter
ApplicantMICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
PMA NumberP100018
Supplement NumberS012
Date Received07/21/2014
Decision Date08/20/2014
Product Code
OUT[ Registered Establishments with OUT ]
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Supplier process changes to the pipeline embolization device.
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