This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for a minor labeling change for the device.
| Device | AQUAFLOW COLLAGEN GLAUCOMA DRAINAGE DEVICES |
| Generic Name | Intraocular Pressure Lowering Implant |
| Applicant | STARR SURGICAL CO. |
| Date Received | 2010-05-01 |
| Decision Date | 2010-06-17 |
| PMA | P000026 |
| Supplement | S003 |
| Product Code | OGO |
| Advisory Committee | Ophthalmic |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | STARR SURGICAL CO. 1911 Walker Ave. monrovia, CA 91016 |
| 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 |