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 | THIMEROSAL PRESERVED SALINE SOLUTION |
| Generic Name | Accessories, Soft Lens Products |
| Applicant | PACO PHARMACEUTICAL SERVICES, INC. |
| Date Received | 1988-05-13 |
| Decision Date | 1988-08-08 |
| PMA | P850047 |
| Supplement | S003 |
| Product Code | LPN |
| Advisory Committee | Ophthalmic |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | PACO PHARMACEUTICAL SERVICES, INC. 1200 Paco Way building 19 lakewood, NJ 08701 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P850047 | Original Filing | |
| S004 | 1989-09-11 | Normal 180 Day Track |
| S003 | 1988-05-13 | Special (immediate Track) |
| S002 | 1988-04-19 | Normal 180 Day Track |
| S001 | 1987-07-10 | 30-Day Supplement |