STAAR SURGICAL COMPANY AQUAFLOW(TM) COLLAGEN GLAUCOMA DRAINAGE DEVICE, MODEL CGDD-20
FDA premarket approval P000026 · decided 2001-07-12
Approval details
- PMA number
- P000026
- Trade name
- STAAR SURGICAL COMPANY AQUAFLOW(TM) COLLAGEN GLAUCOMA DRAINAGE DEVICE, MODEL CGDD-20
- Generic name
- Intraocular pressure lowering implant
- Applicant
- Starr Surgical Co.
- Date received
- 2000-07-07
- Decision date
- 2001-07-12
- Days to decision
- 370 days
- Decision code
- APWD
- Product code
- OGO
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Monrovia, CA
- 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.
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