|
Device | ONYX LIQUID EMBOLIC SYSTEM |
Generic Name | Agent, injectable, embolic |
Applicant | EV3 NEUROVASCULAR 9775 Toledo Way Irvine, CA 92618 |
PMA Number | P030004 |
Date Received | 03/18/2003 |
Decision Date | 07/21/2005 |
Product Code |
MFE |
Docket Number | 05M-0328 |
Notice Date | 08/22/2005 |
Advisory Committee |
Neurology |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR THE ONYX LIQUID EMBOLIC SYSTEM (LES). THE DEVICE IS INDICATED FOR PRESURGICAL EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S005 S006 S007 S008 S009 S010 S011 S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 S025 S026 S027 S028 S029 S030 S031 S033 S034 |