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 two add'l indications, myopic astigmatic prk (prka) and high myopia with and without astigmatism for the device. The device, as modified, will be marketed under the trade name mobilexcimer(r) for ptk and prk. The mobilexcimer(r) for ptk and prk remains indicated for the indications listed in fda's letter of 4/27/97 (p960019/s001 and the new indications contained in this supplement.
| Device | LASERVISION/VISX EXCIMER LASER FOR PRK AND PTK (MOBILEXCIMER) |
| Generic Name | Excimer Laser System |
| Applicant | LASER VISION CENTERS, INC. |
| Date Received | 1998-04-17 |
| Decision Date | 1998-05-05 |
| PMA | P960019 |
| Supplement | S002 |
| Product Code | LZS |
| Advisory Committee | Ophthalmic |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |