PMA supplement
P860022 S054: BOSTON EQUEALENS RIGID GAS/II RIGID GAS PERMEABLE CONTACT LENS
FDA PMA supplement · Normal 180 Day Track · Bausch & Lomb
Key facts
| Original PMA | P860022 |
|---|---|
| Supplement number | S054 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | BOSTON EQUEALENS RIGID GAS/II RIGID GAS PERMEABLE CONTACT LENS |
| Generic name | Lens, contact (rigid gas permeable), extended wear |
| Applicant | Bausch & Lomb |
| Product code | MWL |
| Received date | Jan 30, 2002 |
| Decision date | May 6, 2002 |
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: