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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.
Classification Nameintracranial aneurysm flow diverter
PMA NumberP100018
Supplement NumberS008
Date Received07/24/2013
Decision Date10/22/2013
Product Code
OUT[ Registered Establishments with OUT ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a design change for the shorter pipeline¿ embolization devices (ped), model numbers fa-77xxx-xx, with lengths between 10mm and 20mm. This design change involves replacing the delivery core wire currently available on these shorter ped lengths (rm-00013-xx) with the delivery core wire currently available on the longer ped lengths (rm-00089-xx), model numbers fa-71xxx-xx, between 25mm and 35mm.