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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.
 
Trade NameONYX LIQUID EMBOLIC SYSTEM
Classification Nameagent, injectable, embolic
Generic Nameonyx 18/onyx 34
ApplicantEV3 NEUROVASCULAR
PMA NumberP030004
Supplement NumberS001
Date Received05/25/2006
Decision Date06/22/2006
Product Code
MFE[ Registered Establishments with MFE ]
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Change in the manufacturing instructions to emphasize a continuous mixing process.
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