PMA supplement
P810032 S030: 1CDELS B-13F (P-10) & B-1H (P-11)
FDA PMA supplement · Normal 180 Day Track · Alcon Laboratories
Key facts
| Original PMA | P810032 |
|---|---|
| Supplement number | S030 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | 1CDELS B-13F (P-10) & B-1H (P-11) |
| Generic name | Intraocular lens |
| Applicant | Alcon Laboratories |
| Product code | HQL |
| Received date | Dec 29, 1988 |
| Decision date | Jan 16, 1990 |
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: