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 | APPLIED LABORATORIES STERILE SALINE SOLUTION |
| Generic Name | Accessories, Soft Lens Products |
| Applicant | APPLIED LABORATORIES, INC. |
| Date Received | 1992-03-09 |
| Decision Date | 1993-05-11 |
| PMA | P870002 |
| Supplement | S010 |
| Product Code | LPN |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | APPLIED LABORATORIES, INC. 3240 North Indianapolis Rd. p.o. Box 448 columbus, IN 47201 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P870002 | Original Filing | |
| S012 | 1992-09-23 | Normal 180 Day Track |
| S011 | 1992-04-15 | Normal 180 Day Track |
| S010 | 1992-03-09 | Normal 180 Day Track |
| S009 | 1990-08-28 | Normal 180 Day Track |
| S008 | ||
| S007 | ||
| S006 | 1989-08-24 | Normal 180 Day Track |
| S005 | 1989-08-01 | Normal 180 Day Track |
| S004 | 1989-02-23 | Normal 180 Day Track |
| S003 | 1988-07-25 | 30-Day Supplement |
| S002 | 1988-04-22 | Normal 180 Day Track |
| S001 | 1988-01-27 | Normal 180 Day Track |