PMA supplement
N17367 S012: SOFT MATE(R) DW (HEFILICON A) CONTACT LENS
FDA PMA supplement · Wesley Jessen Corp.
Key facts
| Original PMA | N17367 |
|---|---|
| Supplement number | S012 |
| Trade name | SOFT MATE(R) DW (HEFILICON A) CONTACT LENS |
| Generic name | Sterilizer, soft-lens, thermal, ac-powered |
| Applicant | Wesley Jessen Corp. |
| Product code | HRD |
| Received date | Dec 20, 1983 |
| Decision date | Apr 16, 1984 |
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: