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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameGLAUKOS CORPORATION ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM
Classification Nameintraocular pressure lowering implant
ApplicantGLAUKOS, CORPORATION
PMA NumberP080030
Supplement NumberS001
Date Received06/29/2012
Decision Date11/15/2012
Product Code
OGO[ Registered Establishments with OGO ]
Advisory Committee Ophthalmic
Supplement Type135 review track for 30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the shelf-life extension for two lots of duraflo coating material used in the device.
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