PMA supplement
N18033 S042: VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES/CLEAR & TINTED (VISIBILITY AND COSMETICALLY) WITH UV BLOCKER
FDA PMA supplement · Real-Time Process · Vistakon, Johnson & Johnson Vision Products, Inc.
Key facts
| Original PMA | N18033 |
|---|---|
| Supplement number | S042 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES/CLEAR & TINTED (VISIBILITY AND COSMETICALLY) WITH UV BLOCKER |
| Generic name | Lenses, soft contact, extended wear |
| Applicant | Vistakon, Johnson & Johnson Vision Products, Inc. |
| Product code | LPM |
| Received date | Jun 22, 2009 |
| Decision date | Feb 19, 2010 |
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: