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 | STERILE PRESERVED SALINE SOLUTION |
| Generic Name | Accessories, Soft Lens Products |
| Applicant | STERIDYNE LABORATORIES, INC. |
| Date Received | 1993-12-15 |
| Decision Date | 1994-04-13 |
| PMA | P890067 |
| Supplement | S005 |
| Product Code | LPN |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | STERIDYNE LABORATORIES, INC. 3238 Canyon Lake Dr. los Angeles, CA 90068 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P890067 | Original Filing | |
| S005 | 1993-12-15 | Normal 180 Day Track |
| S004 | 1993-11-30 | Normal 180 Day Track |
| S003 | ||
| S002 | ||
| S001 | 1990-08-16 | Normal 180 Day Track |