iStent inject Trabecular Micro-Bypass System (Model G2-M-IS)

Intraocular Pressure Lowering Implant

FDA Premarket Approval P170043

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the istent inject® trabecular micro-bypass system (model g2-m-is). This device is indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure (iop) in adult patients with mild to moderate primary open-angle glaucoma.

DeviceiStent inject Trabecular Micro-Bypass System (Model G2-M-IS)
Classification NameIntraocular Pressure Lowering Implant
Generic NameIntraocular Pressure Lowering Implant
ApplicantGlaukos Corporation
Date Received2017-12-21
Decision Date2018-06-21
Notice Date2018-07-09
PMAP170043
SupplementS
Product CodeOGO
Docket Number18M-2460
Advisory CommitteeOphthalmic
Expedited ReviewNo
Combination Product No
Applicant Address Glaukos Corporation 229 Avenida Fabricante san Clemente, CA 92672
Summary:Summary of Safety and Effectiveness
Labeling: Labeling Labeling Part 2
Post-Approval Study:Show Report Schedule and Study Progress
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P170043Original Filing
S010 2021-06-15 Normal 180 Day Track
S009 2021-03-25 135 Review Track For 30-day Notice
S008 2020-12-07 Normal 180 Day Track No User Fee
S007 2020-03-03 Normal 180 Day Track No User Fee
S006 2020-03-03 Normal 180 Day Track No User Fee
S005
S004 2019-05-02 30-day Notice
S003
S002 2018-07-23 Normal 180 Day Track No User Fee
S001 2018-07-23 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
00853704002203 P170043 000
00853704002319 P170043 005

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