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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.
 
DeviceiStent inject® W Trabecular Micro-Bypass System
Generic NameIntraocular pressure lowering implant
ApplicantGlaukos Corporation
229 Avenida Fabricante
San Clemente, CA 92672
PMA NumberP170043
Supplement NumberS017
Date Received06/20/2023
Decision Date07/14/2023
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  
Addition of iMark Molding (Woodwille, WI) as an alternative supplier for the Hammer Cam component used in the manufacture of the Glaukos iStent inject® W Trabecular Micro-Bypass System (model G2-W).
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