PMA supplement
P910071 S007: ADATO SIL-OL 5000 SILICONE OIL WITH SYRINGE (CATALOG NUMBER: ES 5000 S)
FDA PMA supplement · Real-Time Process · Bausch & Lomb
Key facts
| Original PMA | P910071 |
|---|---|
| Supplement number | S007 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | ADATO SIL-OL 5000 SILICONE OIL WITH SYRINGE (CATALOG NUMBER: ES 5000 S) |
| Generic name | Fluid, intraocular |
| Applicant | Bausch & Lomb |
| Product code | LWL |
| Received date | Sep 6, 2005 |
| Decision date | Dec 16, 2005 |
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: