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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 NumberS003
Date Received08/01/2011
Decision Date08/30/2011
Product Code
OUT[ Registered Establishments with OUT ]
Advisory Committee Neurology
Supplement Type Special Supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for adding a warning about allergies to metals used in the device and clarifying your instructions for uese.
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