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 | MIRAFLOW EXTRA STRENGTH CLEANER |
Classification Name | Accessories, Soft Lens Products |
Generic Name | Accessories, Soft Lens Products |
Applicant | CIBA VISION CORPORATION |
Date Received | 1987-06-11 |
Decision Date | 1987-07-23 |
PMA | P850055 |
Supplement | S001 |
Product Code | LPN |
Advisory Committee | Ophthalmic |
Supplement Type | 30-Day Supplement |
Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
Expedited Review | No |
Combination Product | No |
Applicant Address | CIBA VISION CORPORATION 11460 Johns Creek Pkwy. duluth, GA 30097 |
Supplement Number | Date | Supplement Type |
---|---|---|
P850055 | Original Filing | |
S009 | 1990-11-01 | Normal 180 Day Track |
S008 | ||
S007 | ||
S006 | 1990-05-09 | Normal 180 Day Track |
S005 | ||
S004 | 1990-02-20 | Normal 180 Day Track |
S003 | 1989-04-17 | Normal 180 Day Track |
S002 | 1988-03-03 | Normal 180 Day Track |
S001 | 1987-06-11 | 30-Day Supplement |