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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 NameTRUFILL N-BUTYL CYANOACRYLATE (N-BCA) LIQUID EMBOLIC SYSTEM
Classification Nametissue adhesive for use in embolization of brain arteriovenous malformations
Generic Nameartificial embolization device
ApplicantCODMAN & SHURTLEFF, INC.
PMA NumberP990040
Supplement NumberS011
Date Received05/10/2010
Decision Date06/09/2010
Product Code
KGG[ Registered Establishments with KGG ]
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Transfer the supplier of the tantalum powder and elimination of redundant elemental analysis and redundant tantalum particle size testing.
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