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 changes to the laser controller; the addition of new user interface including touch-sensitieve screen and rotary knobs; a new integrated power supply with micro-controller electronic components; new labeling; and new software (firmware). The device, as modified, will be marketed under the trade name visulas 690plus and visulink pdt/u adapter and is indicated for use in visudyne therapy as sources of photoactivation of visudyne (verteporfin for injection) for the treatment of patients with predominantly classic subfoveal choroidal neovascularization due to macular degeneration, presumed ocular histoplasmosis or pathologic myopia.
| Device | VISULAS 690 PLUS LASER & VISULINK PDT/U ADAPTER |
| Classification Name | System, Laser, Photodynamic Therapy |
| Generic Name | System, Laser, Photodynamic Therapy |
| Applicant | CARL ZEISS MEDITEC AG |
| Date Received | 2008-04-22 |
| Decision Date | 2008-10-31 |
| PMA | P990048 |
| Supplement | S003 |
| 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 | Yes |
| 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 |