PMA supplement
N16895 S099: SofLens (polymacon) Visibility Tinted Contact Lens
FDA PMA supplement · Real-Time Process · Bausch & Lomb, Inc.
Key facts
| Original PMA | N16895 |
|---|---|
| Supplement number | S099 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | SofLens (polymacon) Visibility Tinted Contact Lens |
| Generic name | Lenses, soft contact, extended wear |
| Applicant | Bausch & Lomb, Inc. |
| Product code | LPM |
| Received date | Jul 21, 2016 |
| Decision date | Dec 27, 2016 |
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: