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 | 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 | 1988-03-31 |
| Decision Date | 1988-10-03 |
| PMA | P840031 |
| Supplement | S007 |
| Product Code | LPM |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| 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 |