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 | SOFTWARE(R) PLUS |
| Generic Name | Accessories, Soft Lens Products |
| Applicant | CIBA VISION CORPORATION |
| Date Received | 1993-07-14 |
| Decision Date | 1994-09-09 |
| PMA | P880079 |
| Supplement | S012 |
| Product Code | LPN |
| 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 | CIBA VISION CORPORATION 11460 Johns Creek Pkwy. duluth, GA 30097 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P880079 | Original Filing | |
| S013 | 1995-01-06 | Normal 180 Day Track |
| S012 | 1993-07-14 | Normal 180 Day Track |
| S011 | 1991-06-04 | Normal 180 Day Track |
| S010 | 1991-05-07 | Special (immediate Track) |
| S009 | ||
| S008 | 1989-11-07 | Normal 180 Day Track |
| S007 | 1989-09-21 | Normal 180 Day Track |
| S006 | ||
| S005 | 1989-07-27 | Normal 180 Day Track |
| S004 | 1989-05-22 | Normal 180 Day Track |
| S003 | 1989-02-03 | Normal 180 Day Track |
| S002 | ||
| S001 | 1988-09-13 | Normal 180 Day Track |