PMA P170013S001

Device
LVIS and LVIS Jr.
Applicant
MicroVention, Inc.
Product code
QCA
Decision date
2020-11-17
Generic name
Intracranial coil-assist stent
Approval order statement
Approval of the revised protocol for the post-approval study (PAS) protocol.

Current openFDA PMA Record#

Device
LVIS and LVIS Jr.
Applicant
MicroVention, Inc.
PMA number
P170013
Supplement
S001
Product code
QCA
Generic name
Intracranial coil-assist stent
Decision date
2020-11-17
Decision code
APPR
Date received
2018-07-26
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol
Approval order statement
Approval of the revised protocol for the post-approval study (PAS) protocol.