PMA P170032S008
- Device
- Woven EndoBridge (WEB) Aneurysm Embolization System
- Applicant
- MicroVention, Inc.
- PMA number
- P170032
- Supplement
- S008
- Product code
- OPR
- Decision date
- 2021-06-01
- Generic name
- Intrasaccular Flow Disruption Device
- Approval order statement
- Updated sampling plan for the quality control inspection step in the WEB over coil subassembly process.
Current openFDA PMA Record#
- Device
- Woven EndoBridge (WEB) Aneurysm Embolization System
- Applicant
- MicroVention, Inc.
- PMA number
- P170032
- Supplement
- S008
- Product code
- OPR
- Generic name
- Intrasaccular Flow Disruption Device
- Decision date
- 2021-06-01
- Decision code
- OK30
- Date received
- 2021-05-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Updated sampling plan for the quality control inspection step in the WEB over coil subassembly process.