|
Device | Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr. X |
Generic Name | Intracranial coil-assist stent |
Applicant | MicroVention, Inc. 35 Enterprise Aliso Viejo, CA 92656 |
PMA Number | P170013 |
Supplement Number | S009 |
Date Received | 06/10/2022 |
Decision Date | 06/28/2022 |
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 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. |