|
Device | Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. |
Generic Name | Intracranial coil-assist stent |
Applicant | MicroVention, Inc. 35 Enterprise Aliso Viejo, CA 92656 |
PMA Number | P170013 |
Supplement Number | S010 |
Date Received | 11/09/2022 |
Decision Date | 12/09/2022 |
Product Code |
QCA |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the revised protocol for the post-approval study (PAS). |