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 | NEODYMIUM-YAG OP LASER OPL-3 |
| Generic Name | Laser, Neodymium:yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla |
| Applicant | COBURN OPTICAL IND., INC. |
| Date Received | 1984-11-07 |
| Decision Date | 1984-12-13 |
| PMA | P830064 |
| Supplement | S002 |
| Product Code | LXS |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | COBURN OPTICAL IND., INC. proffessional Products Div. po Box 2498 clearwater, FL 33517 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P830064 | Original Filing | |
| S003 | 1985-08-08 | |
| S002 | 1984-11-07 | |
| S001 | 1984-10-11 |