PMA P170032S005
- Device
- Woven EndoBridge (WEB) Aneurysm Embolization System
- Applicant
- MicroVention, Inc.
- PMA number
- P170032
- Supplement
- S005
- Product code
- OPR
- Decision date
- 2020-01-23
- Generic name
- Intrasaccular Flow Disruption Device
- Approval order statement
- Change in supplier for a microchip used in the WEB Detachment Controller that is used with the WEB Aneurysm Embolization System.
Current openFDA PMA Record#
- Device
- Woven EndoBridge (WEB) Aneurysm Embolization System
- Applicant
- MicroVention, Inc.
- PMA number
- P170032
- Supplement
- S005
- Product code
- OPR
- Generic name
- Intrasaccular Flow Disruption Device
- Decision date
- 2020-01-23
- Decision code
- OK30
- Date received
- 2019-12-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in supplier for a microchip used in the WEB Detachment Controller that is used with the WEB Aneurysm Embolization System.