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 | SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH |
Classification Name | Accessories, Soft Lens Products |
Generic Name | Accessories, Soft Lens Products |
Applicant | CIBA VISION CARE |
Date Received | 1986-06-27 |
Decision Date | 1986-07-31 |
PMA | P820040 |
Supplement | S011 |
Product Code | LPN |
Advisory Committee | Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | No |
Applicant Address | CIBA VISION CARE 11460 Johns Creek Pkwy. duluth, GA 30136-1518 |
Supplement Number | Date | Supplement Type |
---|---|---|
P820040 | Original Filing | |
S033 | 1995-07-27 | Normal 180 Day Track |
S032 | 1994-09-08 | Normal 180 Day Track |
S031 | 1991-11-05 | Normal 180 Day Track |
S030 | 1991-09-03 | Normal 180 Day Track |
S029 | 1990-11-01 | Normal 180 Day Track |
S028 | ||
S027 | 1990-05-09 | Normal 180 Day Track |
S026 | 1990-03-02 | Normal 180 Day Track |
S025 | 1989-08-29 | Normal 180 Day Track |
S024 | ||
S023 | 1989-01-26 | Normal 180 Day Track |
S022 | 1988-12-08 | Normal 180 Day Track |
S021 | 1988-11-21 | Normal 180 Day Track |
S020 | 1988-04-05 | Normal 180 Day Track |
S019 | 1988-01-27 | Special (immediate Track) |
S018 | ||
S017 | 1987-09-08 | Normal 180 Day Track |
S016 | 1987-08-28 | Normal 180 Day Track |
S015 | 1987-07-16 | Normal 180 Day Track |
S014 | 1987-04-13 | Normal 180 Day Track |
S013 | 1987-04-01 | Normal 180 Day Track |
S012 | 1986-12-03 | 30-Day Supplement |
S011 | 1986-06-27 | Normal 180 Day Track |
S010 | 1986-02-26 | |
S009 | 1985-10-15 | Normal 180 Day Track |
S008 | ||
S007 | 1985-09-30 | |
S006 | 1985-05-20 | |
S005 | 1985-05-02 | |
S004 | 1984-08-30 | |
S003 | 1984-07-17 | |
S002 | 1984-01-03 | |
S001 | 1983-03-24 |