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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® Corporation iStent inject® W Trabecular Micro-Bypass System
Generic NameIntraocular pressure lowering implant
ApplicantGlaukos Corporation
229 Avenida Fabricante
San Clemente, CA 92672
PMA NumberP170043
Supplement NumberS018
Date Received06/29/2023
Decision Date12/20/2023
Product Code OGO 
Advisory Committee Ophthalmic
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
for a change in the sampling plan from 100% inspection to an applicable acceptable quality level (AQL) sampling plan for the singulators manufactured by Resonetics.
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