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.
Approval to add rigid gas permeable contact lenses to the label indications.
| Device | REFRESH CL(TM)/LUBRICATING AND REWETING DROPS |
| Generic Name | Accessories, Soft Lens Products |
| Applicant | ABBOTT MEDICAL OPTICS INC |
| Date Received | 1996-12-23 |
| Decision Date | 1997-04-24 |
| PMA | P960012 |
| Supplement | S001 |
| 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 | ABBOTT MEDICAL OPTICS INC 1700 E. St. Andrew Place santa Ana, CA 92705 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P960012 | Original Filing | |
| S001 | 1996-12-23 | Normal 180 Day Track |