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 for steri-tech, inc. , p. O. Box 1145, salinas, puerto rico 00751 as an alternate contract sterilization site, and for the use of 100% ethylene oxide to sterilize plastic bottles, itps, and caps used in the manufacture of the devices
| Device | WET-N-SOAK |
| Generic Name | Accessories, Soft Lens Products |
| Applicant | ADVANCED MEDICAL OPTICS, INC. |
| Date Received | 1995-06-08 |
| Decision Date | 1996-02-23 |
| PMA | P870037 |
| Supplement | S008 |
| Product Code | LPN |
| 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 | ADVANCED MEDICAL OPTICS, INC. 2525 Dupont Dr. irvine, CA 92612 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P870037 | Original Filing | |
| S008 | 1995-06-08 | Normal 180 Day Track |
| S007 | 1995-05-05 | Normal 180 Day Track |
| S006 | 1989-09-29 | Normal 180 Day Track |
| S005 | 1989-09-07 | Normal 180 Day Track |
| S004 | 1988-12-12 | Normal 180 Day Track |
| S003 | 1988-04-14 | Normal 180 Day Track |
| S002 | 1987-10-30 | Normal 180 Day Track |
| S001 | 1987-10-30 | Normal 180 Day Track |