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 | SUNSOFT (METHAFILOCN A) HYDROPHILIC CONTACT LENS |
Classification Name | Lenses, Soft Contact, Daily Wear |
Generic Name | Lenses, Soft Contact, Daily Wear |
Applicant | COOPER VISION, INC. |
Date Received | 1986-12-11 |
Decision Date | 1987-02-17 |
PMA | P850077 |
Supplement | S004 |
Product Code | LPL |
Advisory Committee | Ophthalmic |
Supplement Type | 30-Day Supplement |
Supplement Reason | Change Design/components/specifications/material |
Expedited Review | No |
Combination Product | No |
Applicant Address | COOPER VISION, INC. 6150 Stoneridge Mall Road suite 370 pleasanton, CA 94588 |
Supplement Number | Date | Supplement Type |
---|---|---|
P850077 | Original Filing | |
S024 | 1997-05-07 | Normal 180 Day Track |
S023 | 1997-04-16 | Normal 180 Day Track |
S022 | 1996-11-22 | Normal 180 Day Track |
S021 | 1994-12-19 | Normal 180 Day Track |
S020 | 1994-09-27 | Normal 180 Day Track |
S019 | 1994-01-26 | Normal 180 Day Track |
S018 | 1992-03-06 | Normal 180 Day Track |
S017 | 1992-02-26 | Normal 180 Day Track |
S016 | ||
S015 | 1991-02-21 | Normal 180 Day Track |
S014 | 1991-01-18 | Normal 180 Day Track |
S013 | 1990-01-05 | Normal 180 Day Track |
S012 | 1989-11-09 | Normal 180 Day Track |
S011 | 1989-07-20 | Normal 180 Day Track |
S010 | 1988-11-14 | Normal 180 Day Track |
S009 | ||
S008 | 1988-04-07 | Normal 180 Day Track |
S007 | ||
S006 | 1988-01-19 | Normal 180 Day Track |
S005 | 1987-11-02 | Normal 180 Day Track |
S004 | 1986-12-11 | 30-Day Supplement |
S003 | ||
S002 | 1986-07-28 | Normal 180 Day Track |
S001 | 1985-10-02 |