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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 NumberS005
Date Received01/26/2012
Decision Date04/05/2012
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 No
Approval Order Statement 
Approval for changes to the instructions for use and patient brochure that strengthen the warnings about catheter entrapment.
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