PMA supplement
P860022 S046: BOSTON EQUALENS(R) AND BOSTON RXD(R)
FDA PMA supplement · Special (Immediate Track) · Bausch & Lomb
Key facts
| Original PMA | P860022 |
|---|---|
| Supplement number | S046 |
| Supplement type | Special (Immediate Track) |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | BOSTON EQUALENS(R) AND BOSTON RXD(R) |
| Generic name | Lens, contact (other material) - daily |
| Applicant | Bausch & Lomb |
| Product code | HQD |
| Received date | Apr 27, 1995 |
| Decision date | Jun 5, 1995 |
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: