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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 TRABECULAR MICRO BYPASS STENT MODEL GTS100R/L
Classification Nameintraocular pressure lowering implant
ApplicantGLAUKOS, CORPORATION
PMA NumberP080030
Supplement NumberS003
Date Received07/20/2012
Decision Date03/05/2013
Product Code
OGO[ Registered Establishments with OGO ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the post-approval study protocol.
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