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.
Approval for an additional manufacturing facility located at ciba vision corp, cidra, puerto rico.
Device | SOFTCON(VIFILCON A) SOFT (HYDROPHILIC) CONTACT LENS(EXTENDED WEAR) |
Generic Name | Lenses, Soft Contact, Extended Wear |
Applicant | Alcon Laboratories, Inc. |
Date Received | 2001-10-16 |
Decision Date | 2001-12-12 |
PMA | P820021 |
Supplement | S030 |
Product Code | LPM |
Advisory Committee | Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Express Gmp Supplement |
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 |