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 | ISOTONIC STERILE UNPRESERVED SALINE SOLUTION |
| Generic Name | Accessories, Soft Lens Products |
| Applicant | VISIONCARE ASSOC. |
| Date Received | 1987-03-30 |
| Decision Date | 1987-06-10 |
| PMA | P860066 |
| Supplement | S001 |
| 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 | VISIONCARE ASSOC. 480 South san Vicente Boulevard los Angeles, CA 90048 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P860066 | Original Filing | |
| S002 | 1988-09-19 | Normal 180 Day Track |
| S001 | 1987-03-30 | Normal 180 Day Track |