- Device
- Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr.
- Applicant
- MicroVention, Inc.
- PMA number
- P170013
- Supplement
- S003
- Product code
- QCA
- Generic name
- Intracranial coil-assist stent
- Decision date
- 2021-02-25
- Decision code
- APPR
- Date received
- 2020-11-24
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site located at MicroVention, Inc., 35 Enterprise, Aliso Viejo, California 92656.