- Device
- Flow Re-Direction Endoluminal Device (FRED) and FRED X System
- Applicant
- MicroVention, Inc.
- PMA number
- P180027
- Supplement
- S006
- Product code
- OUT
- Generic name
- Intracranial aneurysm flow diverter
- Decision date
- 2022-02-15
- Decision code
- APPR
- Date received
- 2021-11-23
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a design change to the introducer sheath from a single-ended taper to a double-ended taper for the FRED System and FRED X System 3.5 to 5.5 mm stents.