PMA P170032S019
- Device
- Woven EndoBridge Aneurysm Embolization (WEB) System
- Applicant
- MicroVention, Inc.
- PMA number
- P170032
- Supplement
- S019
- Product code
- OPR
- Decision date
- 2026-03-20
- Classification
- Neurology
- Generic name
- Intrasaccular Flow Disruption Device
- Approval order statement
- Approval of the revised protocol for the PAS1 PostMarket Surveillance-Long Term Safety post-approval study.
Current openFDA PMA Record#
- Device
- Woven EndoBridge Aneurysm Embolization (WEB) System
- Applicant
- MicroVention, Inc.
- PMA number
- P170032
- Supplement
- S019
- Product code
- OPR
- Generic name
- Intrasaccular Flow Disruption Device
- Decision date
- 2026-03-20
- Decision code
- APPR
- Date received
- 2025-07-03
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the PAS1 PostMarket Surveillance-Long Term Safety post-approval study.