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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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DeviceHYDRUS MICROSTENT
Classification Nameintraocular pressure lowering implant
Generic Nameintraocular pressure lowering implant
Applicant
Ivantis, Inc.
38 discovery, suite 150
irvine, CA 92618
PMA NumberP170034
Date Received10/30/2017
Decision Date08/10/2018
Product Code
OGO[ Registered Establishments with OGO ]
Docket Number 18M-3153
Notice Date 08/13/2018
Advisory Committee Ophthalmic
Clinical Trials NCT01539239
NCT01818115
NCT02023242
NCT02024464
NCT03065036
Expedited Review Granted? No
Combination Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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