This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for a revision to the instructions for use to add a precaution related to the use of magnetic resonance angiography (mra) for follow up assessment following treatment with the lvis and lvis jr. Devices and a revision to the symbols in the instructions for use and the package labeling to align these symbols with the current fda recognized standard.
| 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 | 2018-09-06 |
| Decision Date | 2018-10-06 |
| PMA | P170013 |
| Supplement | S002 |
| Product Code | QCA |
| Advisory Committee | Neurology |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MicroVention, Inc. 1311 Valencia Avenue tustin, CA 92780 |
| 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 |