PMA P170013

Device
Intraluminal Support Device LVIS/LVIS Jr./LVIS EVO
Applicant
MicroVention, Inc.
PMA number
P170013
Supplement
S010
Product code
QCA
Decision date
2026-09-16
Generic name
Intracranial coil-assist stent
Approval order statement
to add automated robotic arms to the existing pickling and etchingmanufacturing processes

Current openFDA PMA Record#

Device
Intraluminal Support Device LVIS/LVIS Jr./LVIS EVO
Applicant
MicroVention, Inc.
PMA number
P170013
Supplement
S013
Product code
QCA
Generic name
Intracranial coil-assist stent
Decision date
2026-09-16
Decision code
OK30
Date received
2026-08-19
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
to add automated robotic arms to the existing pickling and etchingmanufacturing processes