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 | CIBATINT(TM) TINTING PROCESS |
Generic Name | Lenses, Soft Contact, Daily Wear |
Applicant | CIBA VISION CARE |
Date Received | 1989-07-24 |
Decision Date | 1990-01-16 |
PMA | P820086 |
Supplement | S010 |
Product Code | LPL |
Advisory Committee | Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
Expedited Review | No |
Combination Product | No |
Applicant Address | CIBA VISION CARE 11460 Johns Creek Pkwy. duluth, GA 30136-1518 |
Supplement Number | Date | Supplement Type |
---|---|---|
P820086 | Original Filing | |
S012 | 1989-08-01 | Normal 180 Day Track |
S011 | 1989-07-27 | Normal 180 Day Track |
S010 | 1989-07-24 | Normal 180 Day Track |
S009 | ||
S008 | 1988-05-23 | Normal 180 Day Track |
S007 | ||
S006 | 1986-02-20 | |
S005 | 1985-05-10 | |
S004 | 1985-02-07 | |
S003 | 1985-01-17 | |
S002 | ||
S001 | 1984-03-09 |