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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 NumberS006
Date Received11/02/2007
Decision Date11/30/2007
Product Code
KGG[ Registered Establishments with KGG ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to the biological indicators used to monitor the ethylene oxide sterilization cycles (use of a self contained biological indicator in place of a spore strip biological indicator).