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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 Nametissue adhesive for use in embolization of brain arteriovenous malformations
Generic Nameartificial embolization device
PMA NumberP990040
Supplement NumberS004
Date Received04/28/2006
Decision Date06/01/2006
Product Code
KGG[ Registered Establishments with KGG ]
Advisory Committee General & Plastic Surgery
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for revisions to the product label regarding use of the product under high flow conditions, and with ratios of contrast reagent and nbca outside of those ratios tested in the clinical study.