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.
Upgrading the control system in the finn aqua sterilizer fa5.
| Device | FRESHLOOK (PHEMFILCON A) SOFT CONTACT LENSES FOR EXTENDED WEAR |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | Alcon Laboratories, Inc. |
| Date Received | 2011-03-21 |
| Decision Date | 2011-04-21 |
| PMA | P830037 |
| Supplement | S052 |
| 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 |