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 EXT WEAR LENS |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | Alcon Laboratories, Inc. |
| Date Received | 1989-03-01 |
| Decision Date | 1989-05-03 |
| PMA | P820021 |
| Supplement | S016 |
| 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 | Alcon Laboratories, Inc. 6201 South Freeway fort Worth, TX 76134-2099 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P820021 | Original Filing | |
| S036 | 2013-04-10 | 30-day Notice |
| S035 | 2012-11-19 | 30-day Notice |
| S034 | 2012-07-05 | 30-day Notice |
| S033 | 2011-05-09 | 30-day Notice |
| S032 | ||
| S031 | 2006-08-22 | Real-time Process |
| S030 | 2001-10-16 | Normal 180 Day Track |
| S029 | 1996-05-10 | Normal 180 Day Track |
| S028 | 1995-06-27 | Normal 180 Day Track |
| S027 | 1995-05-15 | 30-Day Supplement |
| S026 | 1995-02-17 | Special (immediate Track) |
| S025 | 1995-01-17 | Normal 180 Day Track |
| S024 | 1994-02-02 | Normal 180 Day Track |
| S023 | 1991-04-03 | Normal 180 Day Track |
| S022 | 1990-10-31 | Normal 180 Day Track |
| S021 | 1990-03-28 | Normal 180 Day Track |
| S020 | ||
| S019 | 1989-11-22 | Normal 180 Day Track |
| S018 | 1989-10-10 | Normal 180 Day Track |
| S017 | 1989-07-24 | Normal 180 Day Track |
| S016 | 1989-03-01 | Normal 180 Day Track |
| S015 | 1988-12-21 | Normal 180 Day Track |
| S014 | 1988-05-23 | Normal 180 Day Track |
| S013 | 1988-04-04 | Normal 180 Day Track |
| S012 | 1988-01-12 | Normal 180 Day Track |
| S011 | ||
| S010 | 1987-07-01 | Normal 180 Day Track |
| S009 | 1987-02-02 | Normal 180 Day Track |
| S008 | 1986-03-18 | |
| S007 | 1986-03-04 | |
| S006 | 1986-03-07 | |
| S005 | 1986-02-05 | |
| S004 | ||
| S003 | 1985-01-10 | |
| S002 | 1983-05-17 | |
| S001 | 1983-06-07 |