PMA supplement
P820049 S059: MODELS PS-100A,PS-101A,PS-102A,PS-103A,PS-104A IOL
FDA PMA supplement · Normal 180 Day Track · Advanced Medical Optics, Inc.
Key facts
| Original PMA | P820049 |
|---|---|
| Supplement number | S059 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | MODELS PS-100A,PS-101A,PS-102A,PS-103A,PS-104A IOL |
| Generic name | Intraocular lens |
| Applicant | Advanced Medical Optics, Inc. |
| Product code | HQL |
| Received date | Dec 16, 1993 |
| Decision date | Jun 1, 1995 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: