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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceONYX LIQUID EMBOLIC SYSTEM
Generic NameAgent, injectable, embolic
ApplicantEv3 Neurovascular
9775 Toledo Way
Irvine, CA 92618
PMA NumberP030004
Supplement NumberS012
Date Received12/27/2016
Decision Date01/25/2017
Product Code MFE 
Advisory Committee Neurology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Acceptance for manufacturing equipment/process changes related to the production of the Onyx Liquid Embolic System (LES), which include addition of an alternative cleaning and de-pyrogenation method for the Onyx LES, addition of an alternative dry heat sterilization oven for the Onyx LES, and change of bioburden testing lab for the Onyx vial subassembly.
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