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 | THE SOFT LENS THERMAL DISINFECTING UNIT |
| Generic Name | Sterilizer, Soft-lens, Thermal, Ac-powered |
| Applicant | ABBOTT MEDICAL OPTICS INC |
| Date Received | 1987-06-25 |
| Decision Date | 1987-07-31 |
| PMA | P820082 |
| Supplement | S002 |
| Product Code | HRD |
| Advisory Committee | Ophthalmic |
| Supplement Type | 30-Day Supplement |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |
|---|---|---|
| P820082 | Original Filing | |
| S003 | 1990-02-15 | Normal 180 Day Track |
| S002 | 1987-06-25 | 30-Day Supplement |
| S001 | 1987-01-27 | Normal 180 Day Track |