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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)
Classification Nameintraocular pressure lowering implant
Generic Nameintraocular pressure lowering implant
Applicant
Glaukos Corporation
229 avenida fabricante
san clemente, CA 92672
PMA NumberP170043
Date Received12/21/2017
Decision Date06/21/2018
Product Code
OGO[ Registered Establishments with OGO ]
Docket Number 18M-2460
Notice Date 07/09/2018
Advisory Committee Ophthalmic
Clinical Trials NCT01461291
Expedited Review Granted? No
Combination Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S004 
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