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 inject W Trabecular Micro-Bypass System
• Generic Name: Intraocular pressure lowering implant
• Applicant: Glaukos Corporation; 229 Avenida Fabricante; San Clemente, CA 92672
• PMA Number: P170043
• Supplement Number: S010
• Date Received: 06/15/2021
• Decision Date: 09/10/2021
• Product Code: OGO
• Advisory Committee: Ophthalmic
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/Components/Specifications/Material
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for design changes to the Model G2-W injector.