PMA P180027S012
- Device
- Flow Re-Direction Endoluminal Device (FRED) X System
- Applicant
- MicroVention, Inc.
- PMA number
- P180027
- Supplement
- S012
- Product code
- OUT
- Decision date
- 2025-09-20
- Classification
- Neurology
- Generic name
- Intracranial aneurysm flow diverter
- Approval order statement
- undefined
Current openFDA PMA Record#
- Device
- Flow Re-Direction Endoluminal Device (FRED) X System
- Applicant
- MicroVention, Inc.
- PMA number
- P180027
- Supplement
- S012
- Product code
- OUT
- Generic name
- Intracranial aneurysm flow diverter
- Decision date
- 2025-09-20
- Decision code
- APPR
- Date received
- 2025-04-14
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- undefined