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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 NumberS007
Date Received01/07/2009
Decision Date02/06/2009
Product Code
KGG[ Registered Establishments with KGG ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Changes and modifications as follows: 1) the transfer of the manufacturing of the trufill n-bca liquid embolic system from one building to another within the same facility; 2) a clarification of the instructions for use (1fu) the removal of a redundant incoming receiving inspection for the n-bca and tantalum pouch; 3) the removal of a specification for the n-bca and tantalum pouch; and 4) modification of the seal specifications for the n-bca and tantalum pouch.