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 | SALINE SOLUTION |
| Generic Name | Accessories, Soft Lens Products |
| Applicant | STERIDYNE LABORATORIES, INC. |
| Date Received | 1989-08-10 |
| Decision Date | 1990-04-19 |
| PMA | P880080 |
| Supplement | S002 |
| Product Code | LPN |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | STERIDYNE LABORATORIES, INC. 22 Hillwood Rd. east Brunswick, NJ 08816 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P880080 | Original Filing | |
| S004 | 1991-01-02 | Normal 180 Day Track |
| S003 | ||
| S002 | 1989-08-10 | Normal 180 Day Track |
| S001 | 1989-01-01 | Normal 180 Day Track |