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 | SOFTCON (VIFILCON A) SOFT CONTACT CORRECTIVE LENS |
| Generic Name | Lenses, Soft Contact, Daily Wear |
| Applicant | CIBA VISION CARE |
| Date Received | 1986-02-05 |
| Decision Date | 1987-09-21 |
| PMA | N17554 |
| Supplement | S005 |
| Product Code | LPL |
| 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 | CIBA VISION CARE 11460 Johns Creek Pkwy. duluth, GA 30136-1518 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| N17554 | Original Filing | |
| S012 | 1989-08-01 | Normal 180 Day Track |
| S011 | 1988-05-23 | Normal 180 Day Track |
| S010 | ||
| S009 | ||
| S008 | 1986-03-18 | |
| S007 | 1986-03-04 | |
| S006 | 1985-11-20 | |
| S005 | 1986-02-05 | Normal 180 Day Track |
| S004 | ||
| S003 | 1985-01-17 | |
| S002 | ||
| S001 |