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: GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM
• Generic Name: Intraocular pressure lowering implant
• Applicant: Glaukos Corporation; 26051 Merit Cir.; Suite 103; Laguna Hills, CA 92653
• PMA Number: P080030
• Supplement Number: S017
• Date Received: 05/26/2015
• Decision Date: 05/13/2016
• Product Code: OGO
• Advisory Committee: Ophthalmic
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol - OSB
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Approval for protocol modifications for the PAS2 study.