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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Nameintraocular pressure lowering implant
Generic Nameintraocular pressure lowering implant
26051 merit circle, suite 103
laguna hills, CA 92653
PMA NumberP080030
Date Received12/19/2008
Decision Date06/25/2012
Product Code
OGO[ Registered Establishments with OGO ]
Docket Number 12M-0712
Notice Date 07/16/2012
Advisory Committee Ophthalmic
Clinical Trials NCT00323284
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the glaukos istent® trabecular micro-bypass stent (models: gts-100r, gts-100l) and inserter (gts-l00i). This device is indicated for use in conjunction with cataract surgery for the reduction ofintraocular pressure (iop) in adult patients with mild to moderate open-angle glaucoma currently treated with ocular hypotensive medication.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S016 S017 S018