|
Device | Woven EndoBridge Aneurysm Embolization (WEB) System |
Generic Name | Intrasaccular Flow Disruption Device |
Applicant | MicroVention, Inc. 35 Enterprise Aliso Viejo, CA 92656 |
PMA Number | P170032 |
Supplement Number | S007 |
Date Received | 04/23/2021 |
Decision Date | 07/16/2021 |
Product Code |
OPR |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the change in antioxidants used in the dispenser hoop of packaging of the Flow Re-Direction Endoluminal Device (FRED) System, Woven EndoBridge (WEB) Aneurysm Embolization System and Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. devices. |