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 labeling changes to enhance the instructions to better communicate the proper lens storage timeframes when using the quick care system.
| Device | NDS LENS MAINTENANCE SYSTEM |
| Generic Name | Accessories, Soft Lens Products |
| Applicant | CIBA VISION CORPORATION |
| Date Received | 1995-06-02 |
| Decision Date | 1995-08-01 |
| PMA | P900029 |
| 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 | CIBA VISION CORPORATION 2910 Amwiler Ct. atlanta, GA 30360 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P900029 | Original Filing | |
| S001 | 1995-06-02 | Normal 180 Day Track |