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 | UNISOL |
| Classification Name | Accessories, Soft Lens Products |
| Generic Name | Accessories, Soft Lens Products |
| Applicant | WESLEY JESSEN CORP. |
| Date Received | 1987-06-11 |
| Decision Date | 1987-07-02 |
| PMA | P790011 |
| Supplement | S013 |
| Product Code | LPN |
| Advisory Committee | Ophthalmic |
| Supplement Type | 30-Day Supplement |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | WESLEY JESSEN CORP. 400 West Superior St. chicago, IL 60610 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P790011 | Original Filing | |
| S020 | 1994-08-26 | Special (immediate Track) |
| S019 | ||
| S018 | 1989-05-12 | Normal 180 Day Track |
| S017 | 1989-04-25 | Normal 180 Day Track |
| S016 | 1989-02-13 | Normal 180 Day Track |
| S015 | 1987-11-05 | Normal 180 Day Track |
| S014 | 1987-10-26 | Normal 180 Day Track |
| S013 | 1987-06-11 | 30-Day Supplement |
| S012 | 1987-04-13 | Normal 180 Day Track |
| S011 | 1986-11-18 | Normal 180 Day Track |
| S010 | 1985-04-23 | |
| S009 | 1983-09-13 | |
| S008 | 1983-07-13 | |
| S007 | 1983-04-18 | |
| S006 | 1982-06-25 | |
| S005 | 1982-06-08 | |
| S004 | ||
| S003 | 1981-04-28 | |
| S002 | 1981-04-02 | |
| S001 | 1980-06-24 |