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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
Generic NameIntraocular pressure lowering implant
ApplicantAlcon Research, Ltd
6201 South Freeway
Fort Worth, TX 76134
PMA NumberP150037
Date Received10/21/2015
Decision Date07/29/2016
Withdrawal Date 12/14/2023
Product Code OGO 
Docket Number 16M-2333
Notice Date 08/18/2016
Advisory Committee Ophthalmic
Clinical TrialsNCT01085357
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
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 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 S011 
S014 
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