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# Glaukos PMA for iStent Glaucoma Device
- URL: https://www.fdaweb.com/glaukos-pma-for-istent-glaucoma-device/
- Published: 2018-06-25T12:00:00.000Z
- Updated: 2026-09-15T00:15:48.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5141762

FDA has approved a Glaukos Corp. PMA for the *iStent inject* *Trabecular Micro-Bypass System,* indicated for reducing intraocular pressure in adult mild-to-moderate primary open-angle glaucoma patients undergoing concomitant cataract surgery. The device is designed to “optimize the natural physiological outflow of aqueous humor by creating two patent bypasses through the trabecular meshwork, the main source of resistance in glaucomatous eyes, resulting in multi-directional flow through Schlemm’s canal,” the company says. It includes two heparin-coated titanium stents preloaded into an auto-injection system that allows the surgeon to precisely implant stents into two trabecular meshwork locations through a single corneal entry point.