Approval for use in adults to embolize saccular intracranial wide neck bifurcation aneurysms located in the anterior (middle cerebral artery (mca) bifurcation, internal carotid artery (ica) terminus, anterior communicating artery (acomm) complex) and posterior (basilar apex) circulations, ranging in size from 3 mm to 10 mm in dome diameter, where the neck size is 4 mm or greater or the dome-to-neck ratio is greater than 1 and less than 2.
| Device | Woven EndoBridge (WEB) Aneurysm Embolization System |
| Classification Name | Intrasaccular Flow Disruption Device |
| Generic Name | Intrasaccular Flow Disruption Device |
| Applicant | Sequent Medical, Inc |
| Date Received | 2017-09-28 |
| Decision Date | 2018-12-31 |
| Notice Date | 2019-01-28 |
| PMA | P170032 |
| Supplement | S |
| Product Code | OPR |
| Docket Number | 19M-0027 |
| Advisory Committee | Neurology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Sequent Medical, Inc 11 A Columbia aliso Viejo, CA 92656 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P170032 | Original Filing | |
| S011 | 2021-12-20 | 30-day Notice |
| S010 | 2021-11-22 | 30-day Notice |
| S009 | 2021-07-26 | Real-time Process |
| S008 | 2021-05-06 | 30-day Notice |
| S007 | ||
| S006 | 2020-04-06 | 30-day Notice |
| S005 | 2019-12-26 | 30-day Notice |
| S004 | ||
| S003 | ||
| S002 | 2019-04-05 | Normal 180 Day Track No User Fee |
| S001 |