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 expanding the indications to include use with silicone/acrylate and fluorosilicone/acrylate rigid gas permeable (rgp) contact lenses. When used with rgp lenses, the device will be marketed under the trade name, contaclair(r) rgp multi-purpose solution, and is indicated for use in cleaning, rinsing, disinfecting and storing daily and extended wear rgp contact lenses.
| Device | CONTACLAIR MULTI-PURPOSE SOLUTION |
| Generic Name | Accessories, Soft Lens Products |
| Applicant | EUREKA LABORATORIES, INC. |
| Date Received | 1997-04-18 |
| Decision Date | 1997-07-03 |
| PMA | P910074 |
| Supplement | S001 |
| Product Code | LPN |
| 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 | EUREKA LABORATORIES, INC. chemin Charlemagne 41220 Cellettes |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P910074 | Original Filing | |
| S001 | 1997-04-18 | Normal 180 Day Track |