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 | LOMBART (POLYMACON)POLYMER BUTTONS & LATHE LL-38L |
| Generic Name | Lenses, Soft Contact, Daily Wear |
| Applicant | LOMBART LENSES, LTD. |
| Date Received | 1991-12-20 |
| Decision Date | 1993-05-05 |
| PMA | P880102 |
| Supplement | S002 |
| Product Code | LPL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | LOMBART LENSES, LTD. 1215 Boissevain Ave. norfolk, VA 23507 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P880102 | Original Filing | |
| S002 | 1991-12-20 | Normal 180 Day Track |
| S001 | 1991-07-08 | Normal 180 Day Track |