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 MIRCO-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: S011
• Date Received: 08/01/2014
• Decision Date: 08/29/2014
• Product Code: OGO
• Advisory Committee: Ophthalmic
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
MODIFICATION TO THE ETCHING PROCESS CONSISTING OF THE CHANGES TO THE ETCHING TIME, ACID CONCENTRATION, BATCH SIZE, AND AGITATION METHOD.