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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 NumberS006
Date Received08/21/2012
Decision Date09/18/2012
Product Code
OGO[ Registered Establishments with OGO ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of a second clean room and to perform in house peel testing.
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