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 | THE BLAIREX SYSTEM |
| Generic Name | Accessories, Soft Lens Products |
| Applicant | BLAIREX LABORATORIES, INC. |
| Date Received | 1983-12-21 |
| Decision Date | 1984-05-25 |
| PMA | P800028 |
| Supplement | S010 |
| Product Code | LPN |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BLAIREX LABORATORIES, INC. 4810 Tecumseh Ln, p.o. Box 15190 evansville, IN 47716-0190 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P800028 | Original Filing | |
| S015 | 1987-05-19 | Normal 180 Day Track |
| S014 | 1987-04-20 | Normal 180 Day Track |
| S013 | 1985-11-05 | |
| S012 | 1984-08-09 | |
| S011 | 1984-03-02 | |
| S010 | 1983-12-21 | |
| S009 | 1983-11-15 | |
| S008 | 1983-11-16 | |
| S007 | 1982-08-04 | |
| S006 | 1982-06-01 | |
| S005 | 1982-05-11 | |
| S004 | 1982-04-22 | |
| S003 | 1981-10-27 | |
| S002 | 1981-06-04 | |
| S001 | 1981-06-18 |