PMA supplement
N18033 S033: ACUVUE (ETAFILCON A) CONTACT LENS
FDA PMA supplement · Real-Time Process · Vistakon, Johnson & Johnson Vision Products, Inc.
Key facts
| Original PMA | N18033 |
|---|---|
| Supplement number | S033 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | ACUVUE (ETAFILCON A) CONTACT LENS |
| Generic name | Lenses, soft contact, extended wear |
| Applicant | Vistakon, Johnson & Johnson Vision Products, Inc. |
| Product code | LPM |
| Received date | Apr 1, 1999 |
| Decision date | May 5, 1999 |
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: