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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 NumberS013
Date Received02/09/2015
Decision Date08/07/2015
Product Code OGO 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO UPDATE YOUR LABELING TO INCLUDE THE RESULTS OF YOUR POST-APPROVAL STUDY (PAS) FOR THE ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM, EXTENDED FOLLOW-UP OF THE INVESTIGATIONAL DEVICE EXEMPTION (IDE) COHORT STUDY.
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