This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the low-profile visualized intraluminal support (lvis) and lvis jr. This device is indicated for use with neurovascular embolization coils in patients >= 18 years of age for the treatment of wide-neck (neck width >= 4 mm or dome to neck ratio < 2) saccular intracranial aneurysms arising from a parent vessel with a diameter >= 2. 0 mm and
| Device | Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. |
| Classification Name | Intracranial Coil-assist Stent |
| Generic Name | Intracranial Coil-assist Stent |
| Applicant | MicroVention, Inc. |
| Date Received | 2017-03-31 |
| Decision Date | 2018-05-30 |
| Notice Date | 2018-06-08 |
| PMA | P170013 |
| Supplement | S |
| Product Code | QCA |
| Docket Number | 18M-2118 |
| Advisory Committee | Neurology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MicroVention, Inc. 1311 Valencia Avenue tustin, CA 92780 |
| 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 |
|---|---|---|
| P170013 | Original Filing | |
| S010 | 2022-11-09 | Normal 180 Day Track No User Fee |
| S009 | 2022-06-10 | Normal 180 Day Track No User Fee |
| S008 | ||
| S007 | 2021-09-08 | Normal 180 Day Track No User Fee |
| S006 | 2021-04-23 | Real-time Process |
| S005 | ||
| S004 | ||
| S003 | 2020-11-24 | Normal 180 Day Track No User Fee |
| S002 | 2018-09-06 | Special (immediate Track) |
| S001 |