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 | SATURN II(TM) (SYNERGICON A) CONTACT LENS |
| Classification Name | Lens, Contact (polymethylmethacrylate) |
| Generic Name | Lens, Contact (polymethylmethacrylate) |
| Applicant | WESLEY JESSEN CORP. |
| Date Received | 1989-04-17 |
| Decision Date | 1989-12-06 |
| PMA | P840004 |
| Supplement | S005 |
| Product Code | HPX |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | WESLEY JESSEN CORP. 333 E. Howard Ave. des Plaines, IL 60018-5903 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P840004 | Original Filing | |
| S007 | 1992-11-06 | Normal 180 Day Track |
| S006 | 1992-08-24 | Normal 180 Day Track |
| S005 | 1989-04-17 | Normal 180 Day Track |
| S004 | ||
| S003 | 1986-11-25 | 30-Day Supplement |
| S002 | 1986-04-17 | |
| S001 | 1985-03-12 |