PMA P170013S005
- Device
- Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr.
- Applicant
- MicroVention, Inc.
- Product code
- QCA
- Decision date
- 2021-09-16
- Generic name
- Intracranial coil-assist stent
- 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.
Current openFDA PMA Record#
- Device
- Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr.
- Applicant
- MicroVention, Inc.
- PMA number
- P170013
- Supplement
- S005
- Product code
- QCA
- Generic name
- Intracranial coil-assist stent
- Decision date
- 2021-09-16
- Decision code
- APPR
- Date received
- 2021-03-30
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- 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.