PMA P170013S004

Device: Low-Profile Visualized Intraluminal Support (LVIS), LVIS Jr., LVIS EVO
Applicant: MicroVention, Inc.
Product code: QCA
Decision date: 2022-07-28
Generic name: Intracranial coil-assist stent
Approval order statement: Approval for the new Low-Profile Visualized Intraluminal Support (LVIS) EVO. The LVIS EVO has a modified design compared to the approved LVIS and LVIS Jr. with a change in the radiopacity profile and shorter flared ends of the stent.

Current openFDA PMA Record#

Device: Low-Profile Visualized Intraluminal Support (LVIS), LVIS Jr., LVIS EVO
Applicant: MicroVention, Inc.
PMA number: P170013
Supplement: S004
Product code: QCA
Generic name: Intracranial coil-assist stent
Decision date: 2022-07-28
Decision code: APPR
Date received: 2021-03-12
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the new Low-Profile Visualized Intraluminal Support (LVIS) EVO. The LVIS EVO has a modified design compared to the approved LVIS and LVIS Jr. with a change in the radiopacity profile and shorter flared ends of the stent.