PMA supplement
P880091 S011: UV-ELASTIC POSTERIOR CHAMBER IOL FOR LENS MODEL AA-4207VFHAMBER IOL'S
FDA PMA supplement · Normal 180 Day Track · Staar Surgical Co.
Key facts
| Original PMA | P880091 |
|---|---|
| Supplement number | S011 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | UV-ELASTIC POSTERIOR CHAMBER IOL FOR LENS MODEL AA-4207VFHAMBER IOL'S |
| Generic name | Intraocular lens |
| Applicant | Staar Surgical Co. |
| Product code | HQL |
| Received date | Aug 14, 1997 |
| Decision date | Jul 20, 1998 |
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: