PMA supplement
P820027 S001: SOFTMARK
FDA PMA supplement · Ciba Vision Corporation
Key facts
| Original PMA | P820027 |
|---|---|
| Supplement number | S001 |
| Trade name | SOFTMARK |
| Generic name | System, identification, contact lens |
| Applicant | Ciba Vision Corporation |
| Product code | LOH |
| Received date | Aug 4, 1983 |
| Decision date | Nov 1, 1983 |
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: