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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.
 
DeviceHYDRUS MICROSTENT
Generic NameIntraocular pressure lowering implant
ApplicantIvantis, Inc. wholly-owned subsidiary of Alcon Research, LLC
201 Technology Drive
Irvine, CA 92618
PMA NumberP170034
Date Received10/30/2017
Decision Date08/10/2018
Product Code OGO 
Docket Number 18M-3153
Notice Date 08/13/2018
Advisory Committee Ophthalmic
Clinical TrialsNCT01539239
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Hydrus® Microstent. 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 (POAG).
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 
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