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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
ApplicantEV3 NEUROVASCULAR
PMA NumberP100018
Supplement NumberS004
Date Received09/20/2011
Decision Date03/22/2012
Product Code
OUT[ Registered Establishments with OUT ]
Advisory Committee Neurology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at ev3 neurovascular, irvine, california as an additional manufacturing site for the device.
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