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 | 1989-04-17 |
| Decision Date | 1989-09-14 |
| PMA | P850055 |
| Supplement | S003 |
| Product Code | LPN |
| 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 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 |