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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 ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM
Generic NameIntraocular pressure lowering implant
ApplicantGLAUKOS, CORPORATION
26051 MERIT CIRCLE, SUITE 103
LAGUNA HILLS, CA 92653
PMA NumberP080030
Supplement NumberS016
Date Received05/22/2015
Decision Date07/21/2015
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 CHANGES TO THE POST-APPROVAL STUDY PROTOCOL.
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