PMA supplement
P910056 S056: enVista® hydrophobic acrylic IOL, enVista® toric hydrophobic aryclic IOL, enVista® Aspire™ hydrophobic acrylic IOL, enVi
FDA PMA supplement · 30-Day Notice · Bausch & Lomb, Inc.
Key facts
| Original PMA | P910056 |
|---|---|
| Supplement number | S056 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | enVista® hydrophobic acrylic IOL, enVista® toric hydrophobic aryclic IOL, enVista® Aspire™ hydrophobic acrylic IOL, enVi |
| Generic name | Intraocular lens |
| Applicant | Bausch & Lomb, Inc. |
| Product code | HQL |
| Received date | Jul 16, 2024 |
| Decision date | Aug 7, 2024 |
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: