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 modifications to the visulink pdt adapter in order to make the visulas 790s laser compatible with both zeiss and haag streit slit lamps. The device, as modified, will be marketed under the trade name visulink pdt/u adapter and is indicated for use with the visulas 690s laser therapy as sources of photoactivation of visudyne(verteporfin for injection) for the treatment of age-related macular degeneration (amd) in patients with predominantly classic subfoveal choroidal neovascularization( cnv).
| Device | VISULAS 690S LASER AND VISULINK PDT ADAPTER |
| Classification Name | System, Laser, Photodynamic Therapy |
| Generic Name | System, Laser, Photodynamic Therapy |
| Applicant | CARL ZEISS MEDITEC AG |
| Date Received | 2001-03-09 |
| Decision Date | 2001-07-03 |
| PMA | P990048 |
| Supplement | S002 |
| Product Code | MVF |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |