FDA.reportPublic FDA data

PMA P170013S002

Device
Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr.
Applicant
MicroVention, Inc.
PMA number
P170013
Supplement
S002
Product code
QCA
Decision date
2018-10-06
Classification
Intracranial Coil-assist Stent
Generic name
Intracranial coil-assist stent
Approval order statement
Approval for a revision to the Instructions for Use to add a Precaution related to the use of magnetic resonance angiography (MRA) for follow up assessment following treatment with the LVIS and LVIS Jr. devices and a revision to the symbols in the Instructions for Use and the package labeling to align these symbols with the current FDA recognized standard.

Current openFDA PMA Record#

Device
Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr.
Applicant
MicroVention, Inc.
PMA number
P170013
Supplement
S002
Product code
QCA
Generic name
Intracranial coil-assist stent
Decision date
2018-10-06
Decision code
APPR
Date received
2018-09-06
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for a revision to the Instructions for Use to add a Precaution related to the use of magnetic resonance angiography (MRA) for follow up assessment following treatment with the LVIS and LVIS Jr. devices and a revision to the symbols in the Instructions for Use and the package labeling to align these symbols with the current FDA recognized standard.