PMA supplement
P820040 S012: SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH
FDA PMA supplement · THIRTY DAY TRACK · Ciba Vision Care
Key facts
| Original PMA | P820040 |
|---|---|
| Supplement number | S012 |
| Supplement type | THIRTY DAY TRACK |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | SEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH |
| Generic name | Accessories, soft lens products |
| Applicant | Ciba Vision Care |
| Product code | LPN |
| Received date | Dec 3, 1986 |
| Decision date | Apr 8, 1987 |
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: