- Device
- Woven EndoBridge (WEB) Aneurysm Embolization System
- Applicant
- MicroVention, Inc.
- PMA number
- P170032
- Supplement
- S009
- Product code
- OPR
- Generic name
- Intrasaccular Flow Disruption Device
- Decision date
- 2021-10-14
- Decision code
- APPR
- Date received
- 2021-07-26
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for electron beam (E-beam) radiation as an additional sterilization method for the Woven EndoBridge (WEB) Aneurysm Embolization System.