PMA supplement
P860059 S003: MODEL 304 (ULTRA C-LOOP)
FDA PMA supplement · Panel Track · Advanced Medical Optics, Inc.
Key facts
| Original PMA | P860059 |
|---|---|
| Supplement number | S003 |
| Supplement type | Panel Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | MODEL 304 (ULTRA C-LOOP) |
| Generic name | Intraocular lens |
| Applicant | Advanced Medical Optics, Inc. |
| Product code | HQL |
| Received date | Jan 5, 1988 |
| Decision date | Oct 17, 1988 |
| Docket number | 88M-0384 |
| Notice date | Dec 16, 1988 |
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: