PMA supplement
P910071 S005: ADATO SIL-OIL 5000 SILICONE OIL
FDA PMA supplement · Normal 180 Day Track · Bausch & Lomb
Key facts
| Original PMA | P910071 |
|---|---|
| Supplement number | S005 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | ADATO SIL-OIL 5000 SILICONE OIL |
| Generic name | Fluid, intraocular |
| Applicant | Bausch & Lomb |
| Product code | LWL |
| Received date | Jun 5, 2000 |
| Decision date | Mar 22, 2001 |
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: