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 | VALIDATION/GETINGE ETHYLENE OXIDE STERILIZER |
| Generic Name | Lens, Contact (other Material) - Daily |
| Applicant | ABBOTT MEDICAL OPTICS INC |
| Date Received | 1991-08-09 |
| Decision Date | 1991-08-27 |
| PMA | P880041 |
| Supplement | S002 |
| Product Code | HQD |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| 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 |
|---|---|---|
| P880041 | Original Filing | |
| S002 | 1991-08-09 | Normal 180 Day Track |
| S001 | 1990-03-12 | Normal 180 Day Track |