|
Device | ONYX LIQUID EMBOLIC SYSTEM |
Generic Name | Agent, injectable, embolic |
Applicant | EV3 NEUROVASCULAR 9775 Toledo Way Irvine, CA 92618 |
PMA Number | P030004 |
Supplement Number | S006 |
Date Received | 04/22/2013 |
Decision Date | 05/27/2014 |
Product Code |
MFE |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE APOLLO ONYX DELIVERY MICRO CATHETER THAT WILL BE MANUFACTURED AT MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR IN IRVINE, CALIFORNIA. |
Post-Approval Study | Show Report Schedule and Study Progress |