PMA P170032S003
- Device
- Woven EndoBridge (WEB) Aneurysm Embolization System
- Applicant
- MicroVention, Inc.
- Product code
- OPR
- Decision date
- 2020-02-07
- Generic name
- Intrasaccular Flow Disruption Device
- Approval order statement
- Approval for a new WEB Detachment Controller (WDC-2).
Current openFDA PMA Record#
- Device
- Woven EndoBridge (WEB) Aneurysm Embolization System
- Applicant
- MicroVention, Inc.
- PMA number
- P170032
- Supplement
- S003
- Product code
- OPR
- Generic name
- Intrasaccular Flow Disruption Device
- Decision date
- 2020-02-07
- Decision code
- APPR
- Date received
- 2019-04-19
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a new WEB Detachment Controller (WDC-2).