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 | ULTRAZYME(R) ENZYMATIC CLEANER |
| Generic Name | Accessories, Soft Lens Products |
| Applicant | ADVANCED MEDICAL OPTICS, INC. |
| Date Received | 1994-03-24 |
| Decision Date | 1995-05-25 |
| PMA | P860061 |
| Supplement | S009 |
| 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 | ADVANCED MEDICAL OPTICS, INC. 2525 Dupont Dr. irvine, CA 92612 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P860061 | Original Filing | |
| S010 | 1995-06-06 | Normal 180 Day Track |
| S009 | 1994-03-24 | Normal 180 Day Track |
| S008 | 1993-11-16 | Normal 180 Day Track |
| S007 | 1992-09-11 | Normal 180 Day Track |
| S006 | 1991-10-30 | Normal 180 Day Track |
| S005 | 1989-08-21 | Normal 180 Day Track |
| S004 | 1989-01-25 | Normal 180 Day Track |
| S003 | 1988-03-01 | Normal 180 Day Track |
| S002 | 1987-06-23 | Normal 180 Day Track |
| S001 | 1987-06-08 | Normal 180 Day Track |