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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
Generic NameIntraocular pressure lowering implant
ApplicantGlaukos Corporation
229 Avenida Fabricante
San Clemente, CA 92672
PMA NumberP170043
Supplement NumberS007
Date Received03/03/2020
Decision Date04/30/2020
Product Code OGO 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval of the revised protocol for the post-approval study (PAS) protocol.
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