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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® Trabecular Micro-Bypass Stent System
Generic NameIntraocular pressure lowering implant
ApplicantGlaukos Corporation
26051 Merit Cir.
Suite 103
Laguna Hills, CA 92653
PMA NumberP080030
Supplement NumberS023
Date Received02/04/2022
Decision Date02/18/2022
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  
Change to the sampling plan for Limulus Amebocyte Lysate (LAL) endotoxin testing.
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