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 | LENSRINS(R) STERILE PRESERVED SALINE SOLN |
| Classification Name | Accessories, Soft Lens Products |
| Generic Name | Accessories, Soft Lens Products |
| Applicant | ABBOTT MEDICAL OPTICS INC |
| Date Received | 1987-03-16 |
| Decision Date | 1987-05-05 |
| PMA | P810029 |
| Supplement | S008 |
| 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 | ABBOTT MEDICAL OPTICS INC 1700 E. St. Andrew Place santa Ana, CA 92705 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P810029 | Original Filing | |
| S010 | 1989-09-29 | Normal 180 Day Track |
| S009 | 1988-04-14 | Normal 180 Day Track |
| S008 | 1987-03-16 | 30-Day Supplement |
| S007 | 1984-06-04 | |
| S006 | 1984-04-23 | |
| S005 | 1984-03-26 | |
| S004 | 1982-04-12 | |
| S003 | 1981-06-22 | |
| S002 | 1981-06-16 | Special (immediate Track) |
| S001 | 1980-06-16 |