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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.
 
DeviceCyPass Micro-Stent
Classification Nameintraocular pressure lowering implant
Generic Nameintraocular pressure lowering implant
Applicant
Alcon Research, Ltd
6201 south freeway
fort worth, TX 76134
PMA NumberP150037
Date Received10/21/2015
Decision Date07/29/2016
Product Code
OGO[ Registered Establishments with OGO ]
Docket Number 16M-2333
Notice Date 08/18/2016
Advisory Committee Ophthalmic
Clinical Trials NCT01085357
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the CyPass® System, Model 241-S. 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
Supplements: S001 S002 S003 S004 S005 S006 
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