Approval for the flow re-direction endoluminal device (fred®) system. The flow re-direction endoluminal device (fred®) system is indicated for use in the internal carotid artery from the petrous segment to the terminus for the endovascular treatment of adult patients (22 years of age or older) with wide-necked (neck width >= 4 mm or dome-to-neck ratio < 2) saccular or fusiform intracranial aneurysms arising from a parent vessel with a diameter >= 2. 0 mm and
| Device | Flow Re-Direction Endoluminal (FRED®) System |
| Generic Name | Intracranial Aneurysm Flow Diverter |
| Applicant | MicroVention Terumo |
| Date Received | 2018-08-01 |
| Decision Date | 2019-12-16 |
| PMA | P180027 |
| Supplement | S |
| Product Code | OUT |
| Advisory Committee | Neurology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MicroVention Terumo 35 Enterpricse aliso Viejo, CA 92765 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P180027 | | Original Filing |
| S008 |
2022-03-07 |
30-day Notice |
| S007 |
2022-01-31 |
30-day Notice |
| S006 |
2021-11-23 |
Real-time Process |
| S005 | | |
| S004 |
2021-05-03 |
30-day Notice |
| S003 | | |
| S002 | | |
| S001 |
2020-06-19 |
30-day Notice |
NIH GUDID Devices