PMA P180027S002
- Device
- Flow Re-Direction Endoluminal Device (FRED®) System
- Applicant
- MicroVention, Inc.
- Product code
- OUT
- Decision date
- 2021-09-16
- Generic name
- Intracranial aneurysm flow diverter
- Approval order statement
- Approval for the FRED X System that contains a novel polymer surface treatment on the neurovascular flow-diverting stent.
Current openFDA PMA Record#
- Device
- Flow Re-Direction Endoluminal Device (FRED®) System
- Applicant
- MicroVention, Inc.
- PMA number
- P180027
- Supplement
- S002
- Product code
- OUT
- Generic name
- Intracranial aneurysm flow diverter
- Decision date
- 2021-09-16
- Decision code
- APPR
- Date received
- 2021-03-30
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the FRED X System that contains a novel polymer surface treatment on the neurovascular flow-diverting stent.