PMA supplement
P860022 S060: Boston Equalens (itafluorofocon A) Rigid Gas Permeable Contact Lens, Boston Equalens II (oprifocon A) Rigid Gas Permeabl
FDA PMA supplement · 30-Day Notice · Bausch & Lomb
Key facts
| Original PMA | P860022 |
|---|---|
| Supplement number | S060 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Boston Equalens (itafluorofocon A) Rigid Gas Permeable Contact Lens, Boston Equalens II (oprifocon A) Rigid Gas Permeabl |
| Generic name | Lens, contact (rigid gas permeable), extended wear |
| Applicant | Bausch & Lomb |
| Product code | MWL |
| Received date | Jun 21, 2024 |
| Decision date | Jul 18, 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: