|
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 | S005 |
Date Received | 03/30/2021 |
Decision Date | 09/16/2021 |
Product Code |
QCA |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the LVIS X and LVIS Jr. X that contains a novel polymer surface treatment to the neurovascular coil-assist stent. |
Post-Approval Study | Show Report Schedule and Study Progress |