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 | CIBA VISION(R) STERILE BUFFERED AEROSOL SALINE |
Generic Name | Accessories, Soft Lens Products |
Applicant | CIBA VISION CORPORATION |
Date Received | 1991-06-04 |
Decision Date | 1991-12-03 |
PMA | P880079 |
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 CORPORATION 11460 Johns Creek Pkwy. duluth, GA 30097 |
Supplement Number | Date | Supplement Type |
---|---|---|
P880079 | Original Filing | |
S013 | 1995-01-06 | Normal 180 Day Track |
S012 | 1993-07-14 | Normal 180 Day Track |
S011 | 1991-06-04 | Normal 180 Day Track |
S010 | 1991-05-07 | Special (immediate Track) |
S009 | ||
S008 | 1989-11-07 | Normal 180 Day Track |
S007 | 1989-09-21 | Normal 180 Day Track |
S006 | ||
S005 | 1989-07-27 | Normal 180 Day Track |
S004 | 1989-05-22 | Normal 180 Day Track |
S003 | 1989-02-03 | Normal 180 Day Track |
S002 | ||
S001 | 1988-09-13 | Normal 180 Day Track |