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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 Nameagent, injectable, embolic
Generic Nameonyx 18/onyx 34
PMA NumberP030004
Supplement NumberS003
Date Received09/24/2007
Decision Date10/09/2007
Product Code
MFE[ Registered Establishments with MFE ]
Advisory Committee Neurology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for revision of the product label to include a boxed warning regarding the emission of sparks that occurs when onyx-embolized tissue is surgically resected with monopolar electrocautery devices.