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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: 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.
 
DeviceiStent inject Trabecular Micro-Bypass System (Model G2-M-IS)
Generic NameIntraocular pressure lowering implant
ApplicantGlaukos Corporation
229 Avenida Fabricante
San Clemente, CA 92672
PMA NumberP170043
Date Received12/21/2017
Decision Date06/21/2018
Product Code OGO 
Docket Number 18M-2460
Notice Date 07/09/2018
Advisory Committee Ophthalmic
Clinical TrialsNCT01461291
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
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.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S012 
S013 S014 S016 S017 S018 
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