PMA P170032S021
- Device
- Woven EndoBridge (WEB) Aneurysm Embolization System
- Applicant
- MicroVention, Inc.
- PMA number
- P170032
- Supplement
- S021
- Product code
- OPR
- Decision date
- 2026-05-01
- Classification
- Neurology
- Generic name
- Intrasaccular Flow Disruption Device
- Approval order statement
- approval for an alternate manufacturer of the WEB delivery system subassembly at MicroVention Inc.’s Costa Rica facility
Current openFDA PMA Record#
- Device
- Woven EndoBridge (WEB) Aneurysm Embolization System
- Applicant
- MicroVention, Inc.
- PMA number
- P170032
- Supplement
- S021
- Product code
- OPR
- Generic name
- Intrasaccular Flow Disruption Device
- Decision date
- 2026-05-01
- Decision code
- OK30
- Date received
- 2026-04-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for an alternate manufacturer of the WEB delivery system subassembly at MicroVention Inc.’s Costa Rica facility