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 | BLAIREX STERILE SALINE SOLUTION |
| Classification Name | Accessories, Soft Lens Products |
| Generic Name | Accessories, Soft Lens Products |
| Applicant | BLAIREX LABORATORIES, INC. |
| Date Received | 1988-06-28 |
| Decision Date | 1988-10-28 |
| PMA | P850045 |
| Supplement | S013 |
| 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 | BLAIREX LABORATORIES, INC. 3240 North Indianapolis Rd. p.o. Box 2127 columbus, IN 47201 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P850045 | Original Filing | |
| S016 | 1992-09-24 | Normal 180 Day Track |
| S015 | 1992-09-24 | Normal 180 Day Track |
| S014 | 1989-02-10 | Normal 180 Day Track |
| S013 | 1988-06-28 | Normal 180 Day Track |
| S012 | ||
| S011 | 1988-06-28 | Normal 180 Day Track |
| S010 | 1988-02-09 | Normal 180 Day Track |
| S009 | ||
| S008 | 1987-10-23 | Normal 180 Day Track |
| S007 | ||
| S006 | 1987-09-22 | Normal 180 Day Track |
| S005 | 1987-04-16 | Normal 180 Day Track |
| S004 | 1987-02-19 | Normal 180 Day Track |
| S003 | 1987-01-23 | Normal 180 Day Track |
| S002 | 1986-11-10 | Normal 180 Day Track |
| S001 | 1986-05-02 | Normal 180 Day Track |