PMA supplement
P860022 S048: IPAFLUOROFOCON A AND B
FDA PMA supplement · Normal 180 Day Track · Bausch & Lomb
Key facts
| Original PMA | P860022 |
|---|---|
| Supplement number | S048 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Other |
| Trade name | IPAFLUOROFOCON A AND B |
| Generic name | Lens, contact (other material) - daily |
| Applicant | Bausch & Lomb |
| Product code | HQD |
| Received date | Sep 16, 1997 |
| Decision date | Oct 15, 1997 |
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: