PMA P170032S006
- Device
- Woven EndoBridge (WEB) Aneurysm Embolization System
- Applicant
- MicroVention, Inc.
- PMA number
- P170032
- Supplement
- S006
- Product code
- OPR
- Decision date
- 2020-04-28
- Generic name
- Intrasaccular Flow Disruption Device
- Approval order statement
- the introduction of an additional furnace for the heat set process of the WEB Aneurysm Embolization System implant
Current openFDA PMA Record#
- Device
- Woven EndoBridge (WEB) Aneurysm Embolization System
- Applicant
- MicroVention, Inc.
- PMA number
- P170032
- Supplement
- S006
- Product code
- OPR
- Generic name
- Intrasaccular Flow Disruption Device
- Decision date
- 2020-04-28
- Decision code
- OK30
- Date received
- 2020-04-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the introduction of an additional furnace for the heat set process of the WEB Aneurysm Embolization System implant