PMA supplement
P880079 S010: CIBA VISION(R) STERILE BUFFERED AEROSOL SALINE
FDA PMA supplement · Special (Immediate Track) · Ciba Vision Corporation
Key facts
| Original PMA | P880079 |
|---|---|
| Supplement number | S010 |
| Supplement type | Special (Immediate Track) |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | CIBA VISION(R) STERILE BUFFERED AEROSOL SALINE |
| Generic name | Accessories, soft lens products |
| Applicant | Ciba Vision Corporation |
| Product code | LPN |
| Received date | May 7, 1991 |
| Decision date | Jul 15, 1991 |
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: