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 the laservision(r)/visx excimer laser system model c for ptk and prk to be installed in the calumet coach model mmt-436v semi-trailer coach, which will be manufactured by the calumet coach company, 2150 e. Dalton rd. , calumet city, il 60409-1411. The device, as modified, will be marketed under the trade name mobilexcimer(r) for phototherapeutic keratectomy (ptk) and photorefractive keratectomy (prk) the device indications remained the same
| Device | MOBILEXCIMER FOR PTK AND PRK |
| Generic Name | Excimer Laser System |
| Applicant | LASER VISION CENTERS, INC. |
| Date Received | 1996-11-22 |
| Decision Date | 1997-04-07 |
| PMA | P960019 |
| Supplement | S001 |
| Product Code | LZS |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | LASER VISION CENTERS, INC. 540 Maryville Centre Dr., #200 st. Louis, MO 63141 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P960019 | Original Filing | |
| S002 | 1998-04-17 | Real-time Process |
| S001 | 1996-11-22 | Normal 180 Day Track |