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 age-related macular degeneration, pathologic myopia or presumed ocular histoplasmosis. "
| Device | COHERENT OPAL PHOTOACTIVATOR |
| Classification Name | System, Laser, Photodynamic Therapy |
| Generic Name | System, Laser, Photodynamic Therapy |
| Applicant | LUMENIS |
| Date Received | 2000-08-16 |
| Decision Date | 2001-09-27 |
| PMA | P990049 |
| 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 | LUMENIS 3959 West 1820 South salt Lake City, UT 84104 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P990049 | Original Filing | |
| S001 | 2000-08-16 | Normal 180 Day Track |