PMA supplement
P910071 S012: ADATO SIL-OL 5000 SILICONE OIL
FDA PMA supplement · Normal 180 Day Track No User Fee · Bausch & Lomb
Key facts
| Original PMA | P910071 |
|---|---|
| Supplement number | S012 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | ADATO SIL-OL 5000 SILICONE OIL |
| Generic name | Fluid, intraocular |
| Applicant | Bausch & Lomb |
| Product code | LWL |
| Received date | Jul 7, 2008 |
| Decision date | Aug 22, 2008 |
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: