This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
| Device | SAULFON PW-70 A&B |
| Classification Name | Lenses, Soft Contact, Extended Wear |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | LOMBART LENSES, LTD. |
| Date Received | 1984-07-05 |
| Decision Date | 1985-04-12 |
| Notice Date | 1985-06-19 |
| PMA | P840031 |
| Supplement | S |
| Product Code | LPM |
| Docket Number | 85M-0224 |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | LOMBART LENSES, LTD. 1215 Boissevain Ave. norfolk, VA 23507 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P840031 | Original Filing | |
| S009 | 1998-06-25 | 30-day Notice |
| S008 | 1989-07-19 | Normal 180 Day Track |
| S007 | 1988-03-31 | Normal 180 Day Track |
| S006 | 1987-02-24 | Normal 180 Day Track |
| S005 | ||
| S004 | 1987-02-06 | Normal 180 Day Track |
| S003 | 1985-08-22 | |
| S002 | ||
| S001 | 1985-04-01 |