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 revision of the indication for use statement to read "for the treatment of patients with predominantly classic subfoveal choroidal neovascularization due to macular degeneration, presumed ocular histoplasmosis, or pathologic myopia. "
| Device | VISULAS 690S AND VISULINK PDT/U ADAPTER |
| Classification Name | System, Laser, Photodynamic Therapy |
| Generic Name | System, Laser, Photodynamic Therapy |
| Applicant | CARL ZEISS MEDITEC AG |
| Date Received | 2000-08-14 |
| Decision Date | 2001-09-27 |
| PMA | P990048 |
| Supplement | S001 |
| Product Code | MVF |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CARL ZEISS MEDITEC AG 5160 Hacienda Drive dublin, CA 94568 |
| 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 |