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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
ApplicantCHESTNUT MEDICAL TECHNOLOGIES, INC.
PMA NumberP100018
Supplement NumberS001
Date Received04/28/2011
Decision Date06/27/2011
Product Code
OUT[ Registered Establishments with OUT ]
Advisory Committee Neurology
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of post- approval study protocol.
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