PMA supplement
P790027 S034: CHAMBER LENS MODELS 101, 101B, 101T
FDA PMA supplement · Panel Track · Bausch & Lomb
Key facts
| Original PMA | P790027 |
|---|---|
| Supplement number | S034 |
| Supplement type | Panel Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | CHAMBER LENS MODELS 101, 101B, 101T |
| Generic name | Intraocular lens |
| Applicant | Bausch & Lomb |
| Product code | HQL |
| Received date | Apr 18, 1988 |
| Decision date | Aug 18, 1989 |
| Docket number | 89M-0353 |
| Notice date | Apr 5, 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: