CyPass Micro-Stent

FDA premarket approval P150037 · Intraocular pressure lowering implant

PMA numberP150037

Approval

Applicant
Alcon Research, Ltd.
Received
October 21, 2015
Decision date
July 29, 2016 (APWD)
Supplements
12, latest April 9, 2020
Product code
OGO – Intraocular Pressure Lowering Implant

Official FDA PMA record

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).