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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 Trabecular Micro-Bypass System (Model G2-M-IS)
Classification Nameintraocular pressure lowering implant
Generic Nameintraocular pressure lowering implant
Applicant
Glaukos Corporation
229 avenida fabricante
san clemente, CA 92672
PMA NumberP170043
Supplement NumberS004
Date Received05/02/2019
Decision Date05/30/2019
Product Code
OGO[ Registered Establishments with OGO ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Modification to the endotoxin specification for the injector handpiece for the Glaukos® iStent inject® Trabecular Micro-Bypass System (Model G2-M-IS).
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