PMA supplement
N18033 S029: ACUVUE(R) (ETAFILCON A) EXTENDED WEAR CONTACT LENS (CLEAR AND TINTED WITH UV BLOCKER)
FDA PMA supplement · Normal 180 Day Track · Vistakon, Johnson & Johnson Vision Products, Inc.
Key facts
| Original PMA | N18033 |
|---|---|
| Supplement number | S029 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | ACUVUE(R) (ETAFILCON A) EXTENDED WEAR CONTACT LENS (CLEAR AND TINTED WITH UV BLOCKER) |
| Generic name | Lenses, soft contact, extended wear |
| Applicant | Vistakon, Johnson & Johnson Vision Products, Inc. |
| Product code | LPM |
| Received date | Jul 18, 1996 |
| Decision date | Oct 7, 1996 |
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: