Low-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr.

FDA Premarket Approval P170013 S007

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval of the revised protocol for the post-approval study (pas).

DeviceLow-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr.
Generic NameIntracranial Coil-assist Stent
ApplicantMicroVention, Inc.
Date Received2021-09-08
Decision Date2021-10-08
PMAP170013
SupplementS007
Product CodeQCA 
Advisory CommitteeNeurology
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol
Expedited ReviewNo
Combination Product No
Applicant Address MicroVention, Inc. 1311 Valencia Avenue tustin, CA 92780

Supplemental Filings

Supplement NumberDateSupplement Type
P170013Original Filing
S007 2021-09-08 Normal 180 Day Track No User Fee
S006 2021-04-23 Real-time Process
S005
S004
S003 2020-11-24 Normal 180 Day Track No User Fee
S002 2018-09-06 Special (immediate Track)
S001

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