PMA supplement
P800049 S006: ZIRCONIA SILICATE BEAD IOL TUMBLE POLISHING
FDA PMA supplement · Normal 180 Day Track · Alcon
Key facts
| Original PMA | P800049 |
|---|---|
| Supplement number | S006 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | ZIRCONIA SILICATE BEAD IOL TUMBLE POLISHING |
| Generic name | Intraocular lens |
| Applicant | Alcon |
| Product code | HQL |
| Received date | Jan 31, 1995 |
| Decision date | Jul 24, 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: