PMA P180027S014
- Device
- FRED X System
- Applicant
- MicroVention, Inc.
- PMA number
- P180027
- Supplement
- S014
- Product code
- OUT
- Decision date
- 2025-09-18
- Classification
- Neurology
- Generic name
- Intracranial aneurysm flow diverter
- Approval order statement
- Approval of claims regarding reduced acute material thrombogenicity supported by in-vitro testing on a proprietary device surface modification.
Current openFDA PMA Record#
- Device
- FRED X System
- Applicant
- MicroVention, Inc.
- PMA number
- P180027
- Supplement
- S014
- Product code
- OUT
- Generic name
- Intracranial aneurysm flow diverter
- Decision date
- 2025-09-18
- Decision code
- APPR
- Date received
- 2025-06-20
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval of claims regarding reduced acute material thrombogenicity supported by in-vitro testing on a proprietary device surface modification.