- Device
- Woven EndoBridge (WEB) Aneurysm Embolization System
- Applicant
- MicroVention, Inc.
- PMA number
- P170032
- Supplement
- S014
- Product code
- OPR
- Generic name
- Intrasaccular Flow Disruption Device
- Decision date
- 2023-11-24
- Decision code
- APPR
- Date received
- 2023-08-03
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for the tether diameter and manufacturing process change for the W5 models of the Woven EndoBridge (WEB) Aneurysm Embolization System