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 the change in antioxidants used in the dispenser hoop of packaging of the flow re-direction endoluminal device (fred) system, woven endobridge (web) aneurysm embolization system and low-profile visualized intraluminal support (lvis) and lvis jr. Devices.
| Device | Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. |
| Generic Name | Intracranial Coil-assist Stent |
| Applicant | MicroVention, Inc. |
| Date Received | 2021-04-23 |
| Decision Date | 2021-07-16 |
| PMA | P170013 |
| Supplement | S006 |
| Product Code | QCA |
| Advisory Committee | Neurology |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |