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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 NumberS019
Date Received11/07/2016
Decision Date12/05/2016
Product Code OGO 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Modifications to the clean room and moving of the purchasing controls, receiving acceptance, and final packaging/acceptance operations to the San Clemente manufacturing site.
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