Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: iStent® Trabecular Mjcro-Bypass Stent System, Model GTS100
• Generic Name: Intraocular pressure lowering implant
• Applicant: Glaukos Corporation; 26051 Merit Cir.; Suite 103; Laguna Hills, CA 92653
• PMA Number: P080030
• Supplement Number: S026
• Date Received: 10/05/2023
• Decision Date: 03/28/2024
• Product Code: OGO
• Advisory Committee: Ophthalmic
• Clinical Trials: NCT00323284
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Labeling Change - PAS
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Request for approval of labeling changes made to the Directions for Use and Package Insert.