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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 Trabecular Micro-Bypass Stent System
Generic NameIntraocular pressure lowering implant
ApplicantGlaukos Corporation
26051 Merit Cir.
Suite 103
Laguna Hills, CA 92653
PMA NumberP080030
Supplement NumberS020
Date Received02/13/2017
Decision Date02/06/2018
Product Code OGO 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for modifications to the Models GTS100R and GTS100L stents, which are part of the iStent® Trabecular Micro- Bypass Stent System and approval for an alternate supplier for the stents.
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