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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 NumberS002
Date Received07/23/2018
Decision Date04/16/2019
Product Code
OGO[ Registered Establishments with OGO ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval study protocol - ode/oir
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the revised protocol for the post-approval study (PAS) protocol.
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