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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceGlaukos® iStent inject® W Trabecular Micro-Bypass System, Glaukos® iStent inject® W Trabecular Micro-Bypass System with
Generic NameIntraocular pressure lowering implant
ApplicantGlaukos Corporation
229 Avenida Fabricante
San Clemente, CA 92672
PMA NumberP170043
Supplement NumberS023
Date Received09/01/2026
Decision Date10/01/2026
Product Code OGO 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
four changes including Instruction for Use change from printed to electronic format, updated sustainable shipper box, reduced incoming inspection sampling plan for Trocar component, and addition of alternative location for final packaging, labeling and lot release operations on the existing manufacturing campus
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