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.
| Device | Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. X |
| Generic Name | Intracranial Coil-assist Stent |
| Applicant | MicroVention, Inc.35 Enterprisealiso Viejo, CA 92656 PMA NumberP170013 Supplement NumberS009 Date Received06/10/2022 Decision Date06/28/2022 Product Code QCA Advisory Committee Neurology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No |
| Date Received | 2022-06-10 |
| Decision Date | 2022-06-28 |
| PMA | P170013 |
| Supplement | S009 |
| Product Code | QCA |
| Advisory Committee | Neurology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MicroVention, Inc. 35 Enterprise aliso Viejo, CA 92656 PMA NumberP170013 Supplement NumberS009 Date Received06/10/2022 Decision Date06/28/2022 Product Code QCA Advisory Committee Neurology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval To Place The Post-approval Study Titled “LVIS X PAS” On Hold, Because The Sponsor Does Not Intend To Market The LVIS X And LVIS Jr. X Devices In The United States At This Time. |
| 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 |