This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
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.
| Device | 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 |
| Notice Date | 2001-07-23 |
| PMA | P000026 |
| Supplement | S |
| Product Code | OGO |
| Docket Number | 01M-0307 |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | STARR SURGICAL CO. 1911 Walker Ave. monrovia, CA 91016 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P000026 | Original Filing | |
| S003 | 2010-05-01 | Real-time Process |
| S002 | 2009-02-09 | 30-day Notice |
| S001 | 2008-07-23 | 135 Review Track For 30-day Notice |