Premarket Approval (PMA)

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.

• Device: CyPass Micro-Stent
• Generic Name: Intraocular pressure lowering implant
• Applicant: Alcon Research, Ltd.; 6201 S. Fwy.; Fort Worth, TX 76134
• PMA Number: P150037
• Date Received: 10/21/2015
• Decision Date: 07/29/2016
• Withdrawal Date: 12/14/2023
• Product Code: OGO
• Docket Number: 16M-2333
• Notice Date: 08/18/2016
• Advisory Committee: Ophthalmic
• Clinical Trials: NCT01085357
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No
• Recalls: CDRH 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 Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling; Labeling Part 2
• Post-Approval Study: Show Report Schedule and Study Progress
• Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 ; S014