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 addition of ciba vision's solocare(tm) brand multi-purpose solution to the labeling of the unizyme(tm) enzymatic cleaner as a diluent to be used sequentially with the unizyme(tm) enzyme.
| Device | UNIZYME(TM) ENZYMATIC CLEANER |
| Generic Name | Accessories, Solution, Ultrasonic Cleaners For Lenses |
| Applicant | CIBA VISION CORPORATION |
| Date Received | 1997-04-15 |
| Decision Date | 1997-07-03 |
| PMA | P960024 |
| Supplement | S001 |
| Product Code | LYL |
| 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 | CIBA VISION CORPORATION 11460 Johns Creek Pkwy. duluth, GA 30097 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P960024 | Original Filing | |
| S001 | 1997-04-15 | Real-time Process |