PMA supplement
P830070 S004: AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR
FDA PMA supplement · Panel Track · Ciba Vision Corporation
Key facts
| Original PMA | P830070 |
|---|---|
| Supplement number | S004 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | AIRLENS(R) (AIRFOCON A) CONTACT LENS BLUE & CLEAR |
| Generic name | Lens, contact (polymethylmethacrylate) |
| Applicant | Ciba Vision Corporation |
| Product code | HPX |
| Received date | Aug 1, 1986 |
| Decision date | Apr 13, 1988 |
| Docket number | 88M-0185 |
| Notice date | Jun 27, 1988 |
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: