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 to add an ultra violet absorber to the clear and litetine lathe cut polymer rods for the subject devices. The devices, as modified, will be marketed under the trade names durasoft(r)3 and durasoft(r)3 uv (phemfilcon a) spherical and optifit(r) toric clear, litetint, colors, and color complements soft (hydrophilic) contact lenses (lathe cut) for extended wear with no change in the currently approved indications for use.
Device | DURASOFT 3 (PHEMFILCON A) UV OPTIFIT TORIC AND SPHERICAL CONTACT LENSES |
Generic Name | Lenses, Soft Contact, Extended Wear |
Applicant | Alcon Laboratories, Inc. |
Date Received | 1996-12-18 |
Decision Date | 1997-05-15 |
PMA | P830037 |
Supplement | S040 |
Product Code | LPM |
Advisory Committee | Ophthalmic |
Supplement Type | Normal 180 Day Track |
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 |