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Device | STAAR SURGICAL COMPANY AQUAFLOW(TM) COLLAGEN GLAUCOMA DRAINAGE DEVICE, MODEL CGDD-20 |
Generic Name | Intraocular pressure lowering implant |
Applicant | STARR SURGICAL CO. 1911 WALKER AVE. MONROVIA, CA 91016 |
PMA Number | P000026 |
Date Received | 07/07/2000 |
Decision Date | 07/12/2001 |
Withdrawal Date
|
07/01/2020 |
Product Code |
OGO |
Docket Number | 01M-0307 |
Notice Date | 07/23/2001 |
Advisory Committee |
Ophthalmic |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE MODEL CGDD-20 AQUAFLOW(TM) COLLAGEN DRAINAGE DEVICE. THE DEVICE IS INDICATED FOR THE MAINTENANCE OF A SUB-SCLERAL SPACE FOLLOWING NON-PENETRATING DEEP SCLERECTOMY USED TO FACILITATE AQUEOUS OUTFLOW FOR THE REDUCTION OF INTRAOCULAR PRESSURE IN PATIENTS WITH OPEN ANGLE GLAUCOMA WHERE INTRAOCULAR PRESSURE REMAINS UNCONTROLLED WHILE ON MAXIMALLY TOLERATED MEDICAL THERAPY. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Supplements: |
S001 S002 S003 |