PMA supplement
P170035 S019: Bausch + Lomb Ultra (Samfilcon A) Visibly Tinted (Soft) Contact Lenses
FDA PMA supplement · 30-Day Notice · Bausch and Lomb, Inc.,
Key facts
| Original PMA | P170035 |
|---|---|
| Supplement number | S019 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Bausch + Lomb Ultra (Samfilcon A) Visibly Tinted (Soft) Contact Lenses |
| Generic name | Lenses, soft contact, extended wear |
| Applicant | Bausch and Lomb, Inc., |
| Product code | LPM |
| Received date | Oct 3, 2025 |
| Decision date | Dec 4, 2025 |
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: