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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 NumberS001
Date Received03/01/2001
Decision Date05/30/2001
Product Code
KGG[ Registered Establishments with KGG ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for removal of the post ethylene oxide sterilization pyrogen test of the n-bca, removal of the post-sterilization functional testing of the tantalum powder, the addition of a pyrogen test of the tantalum powder, and the validation of the pyrogenicity test.