|
Device | GLAUKOS ISTENT TRABECULAR BYPASS STENT MODEL GTS100R/L |
Generic Name | Intraocular pressure lowering implant |
Applicant | GLAUKOS, CORPORATION 26051 MERIT CIRCLE, SUITE 103 LAGUNA HILLS, CA 92653 |
PMA Number | P080030 |
Date Received | 12/19/2008 |
Decision Date | 06/25/2012 |
Product Code |
OGO |
Docket Number | 12M-0712 |
Notice Date | 07/16/2012 |
Advisory Committee |
Ophthalmic |
Clinical Trials | NCT00323284
|
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE GLAUKOS ISTENT® TRABECULAR MICRO-BYPASS STENT (MODELS: GTS-100R, GTS-100L) AND INSERTER (GTS-L00I). THIS DEVICE IS INDICATED FOR USE IN CONJUNCTION WITH CATARACT SURGERY FOR THE REDUCTION OFINTRAOCULAR PRESSURE (IOP) IN ADULT PATIENTS WITH MILD TO MODERATE OPEN-ANGLE GLAUCOMA CURRENTLY TREATED WITH OCULAR HYPOTENSIVE MEDICATION. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 S012 S013 S014 S016 S017 S018 S019 S020 S021 S022 S023 S024 S026 |