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. |
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Device | ONYX LIQUID EMBOLIC SYSTEM |
Generic Name | Agent, injectable, embolic |
Applicant | EV3 NEUROVASCULAR 9775 Toledo Way Irvine, CA 92618 |
PMA Number | P030004 |
Supplement Number | S012 |
Date Received | 12/27/2016 |
Decision Date | 01/25/2017 |
Product Code |
MFE |
Advisory Committee |
Neurology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
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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