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.
| Device | PHOTOTOME(TM) SYSTEM 2700 |
| Generic Name | Laser, Neodymium:yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary |
| Applicant | LASER MEDIA |
| Date Received | 1986-09-08 |
| Decision Date | 1987-01-09 |
| PMA | P850019 |
| Supplement | S002 |
| Product Code | LOI |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | LASER MEDIA 77 Arkay Dr. hauppauge, NY 11788 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P850019 | Original Filing | |
| S002 | 1986-09-08 | Normal 180 Day Track |
| S001 | 1985-10-28 |