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 treatment of age-related macular degeneration in patients with predominantly classic subfoveal choroidal neovascularization.
| Device | ZEISS VISULAS 690 LASER AND VISULINK PDT ADAPTER |
| Classification Name | System, Laser, Photodynamic Therapy |
| Generic Name | System, Laser, Photodynamic Therapy |
| Applicant | CARL ZEISS MEDITEC AG |
| Date Received | 1999-08-16 |
| Decision Date | 2000-04-12 |
| Notice Date | 2000-04-12 |
| PMA | P990048 |
| Supplement | S |
| Product Code | MVF |
| Docket Number | 00M-1300 |
| Advisory Committee | General & Plastic Surgery |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | CARL ZEISS MEDITEC AG 5160 Hacienda Drive dublin, CA 94568 |
| Summary: | Summary of Safety and Effectiveness |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P990048 | Original Filing | |
| S003 | 2008-04-22 | Normal 180 Day Track |
| S002 | 2001-03-09 | Normal 180 Day Track |
| S001 | 2000-08-14 | Normal 180 Day Track |