PMA supplement
N16895 S094: BAUSCH & LOMB SOFLENS 38 (POLYMACON) SOFT CONTACT LENSES
FDA PMA supplement · 135 Review Track For 30-Day Notice · Bausch & Lomb, Inc.
Key facts
| Original PMA | N16895 |
|---|---|
| Supplement number | S094 |
| Supplement type | 135 Review Track For 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | BAUSCH & LOMB SOFLENS 38 (POLYMACON) SOFT CONTACT LENSES |
| Generic name | Lenses, soft contact, extended wear |
| Applicant | Bausch & Lomb, Inc. |
| Product code | LPM |
| Received date | Oct 19, 2011 |
| Decision date | May 2, 2014 |
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: