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

FDA Premarket Approval P170013 S006

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 for the change in antioxidants used in the dispenser hoop of packaging of the flow re-direction endoluminal device (fred) system, woven endobridge (web) aneurysm embolization system and low-profile visualized intraluminal support (lvis) and lvis jr. Devices.

DeviceLow-Profile Visualized Intraluminal Support (LVIS) and LVIS Jr.
Generic NameIntracranial Coil-assist Stent
ApplicantMicroVention, Inc.
Date Received2021-04-23
Decision Date2021-07-16
PMAP170013
SupplementS006
Product CodeQCA 
Advisory CommitteeNeurology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address MicroVention, Inc. 1311 Valencia Avenue tustin, CA 92780

Supplemental Filings

Supplement NumberDateSupplement Type
P170013Original Filing
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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