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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.
 
DeviceGLAUKOS ISTENT TRABECULAR BYPASS STENT MODEL GTS100R/L
Classification Nameintraocular pressure lowering implant
Generic Nameintraocular pressure lowering implant
Applicant
GLAUKOS, CORPORATION
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 S019 
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