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.
Change to the production of casting cups.
| Device | EXTENDED WEAR SOFT CONTACT LENS |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | Alcon Laboratories, Inc. |
| Date Received | 2012-10-04 |
| Decision Date | 2012-11-08 |
| PMA | P830037 |
| Supplement | S054 |
| Product Code | LPM |
| Advisory Committee | Ophthalmic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process 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 |
|---|---|---|
| P830037 | Original Filing | |
| S054 | 2012-10-04 | 30-day Notice |
| S053 | 2011-09-23 | Normal 180 Day Track |
| S052 | 2011-03-21 | 30-day Notice |
| S051 | 2010-12-13 | 30-day Notice |
| S050 | ||
| S049 | ||
| S048 | 2003-02-07 | Real-time Process |
| S047 | 2002-10-25 | Real-time Process |
| S046 | 2002-07-16 | Normal 180 Day Track |
| S045 | 2002-03-28 | Real-time Process |
| S044 | 2001-03-05 | 135 Review Track For 30-day Notice |
| S043 | 2000-10-10 | Normal 180 Day Track |
| S042 | 1999-04-07 | Real-time Process |
| S041 | 1998-07-06 | Normal 180 Day Track |
| S040 | 1996-12-18 | Normal 180 Day Track |
| S039 | 1995-10-02 | Normal 180 Day Track |
| S038 | 1994-05-01 | 30-Day Supplement |
| S037 | 1994-04-11 | Normal 180 Day Track |
| S036 | 1994-03-28 | Normal 180 Day Track |
| S035 | 1993-08-13 | Normal 180 Day Track |
| S034 | 1993-02-26 | Normal 180 Day Track |
| S033 | 1991-05-31 | Normal 180 Day Track |
| S032 | 1991-04-10 | Normal 180 Day Track |
| S031 | 1989-09-18 | Normal 180 Day Track |
| S030 | 1989-09-11 | Normal 180 Day Track |
| S029 | 1989-09-05 | Normal 180 Day Track |
| S028 | 1989-08-07 | Normal 180 Day Track |
| S027 | 1989-08-01 | Normal 180 Day Track |
| S026 | 1989-07-20 | Normal 180 Day Track |
| S025 | 1989-06-19 | Normal 180 Day Track |
| S024 | 1989-03-17 | Normal 180 Day Track |
| S023 | 1989-02-09 | Normal 180 Day Track |
| S022 | 1988-12-16 | Normal 180 Day Track |
| S021 | 1987-07-29 | Normal 180 Day Track |
| S020 | 1987-07-30 | Normal 180 Day Track |
| S019 | 1987-07-27 | Normal 180 Day Track |
| S018 | 1987-07-28 | Normal 180 Day Track |
| S017 | ||
| S016 | 1987-07-27 | Normal 180 Day Track |
| S015 | 1987-06-08 | Normal 180 Day Track |
| S014 | 1987-05-20 | Normal 180 Day Track |
| S013 | 1987-04-09 | Normal 180 Day Track |
| S012 | 1987-01-15 | Normal 180 Day Track |
| S011 | 1986-12-15 | Normal 180 Day Track |
| S010 | 1986-12-15 | Normal 180 Day Track |
| S009 | 1986-10-08 | Special (immediate Track) |
| S008 | 1985-11-04 | |
| S007 | 1985-10-04 | |
| S006 | 1985-07-23 | |
| S005 | 1985-06-18 | 30-Day Supplement |
| S004 | 1984-11-21 | |
| S003 | 1984-06-21 | |
| S002 | ||
| S001 | 1984-04-27 |