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 use of device (small tablet formulation) in lens cases with volumes ranging from 1. 8ml to 4ml per well
| Device | ULTRAZYME(R) ENZYMATIC CLEANER |
| Generic Name | Accessories, Soft Lens Products |
| Applicant | ADVANCED MEDICAL OPTICS, INC. |
| Date Received | 1995-06-06 |
| Decision Date | 1995-10-11 |
| PMA | P860061 |
| Supplement | S010 |
| Product Code | LPN |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |