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 | MODEL NO. ALS-IV HEAT DISINFECTION UNIT |
| Generic Name | Sterilizer, Soft-lens, Thermal, Ac-powered |
| Applicant | ABBOTT MEDICAL OPTICS INC |
| Date Received | 1987-12-04 |
| Decision Date | 1988-05-10 |
| PMA | P840054 |
| Supplement | S001 |
| Product Code | HRD |
| Advisory Committee | Ophthalmic |
| Supplement Type | Special (immediate 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 |
|---|---|---|
| P840054 | Original Filing | |
| S001 | 1987-12-04 | Special (immediate Track) |