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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 Cir.
Suite 103
Laguna Hills, CA 92653
PMA NumberP080030
Supplement NumberS014
Date Received02/11/2015
Decision Date03/24/2015
Product Code OGO 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO UPDATE THE MAGNETIC RESONANCE IMAGING (MRI) INFORMATION IN THE INSTRUCTION FOR USE AND PATIENT ID CARD OF THE ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM.
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