PMA
P840031: SAULFON PW-70 A&B
FDA PMA · Lenses, soft contact, extended wear · Lombart Lenses, Ltd.
Key facts
| PMA number | P840031 |
|---|---|
| Trade name | SAULFON PW-70 A&B |
| Generic name | Lenses, soft contact, extended wear |
| Applicant | Lombart Lenses, Ltd. |
| Product code | LPM |
| Approval date | Apr 12, 1985 |
| Docket number | 85M-0224 |
| Notice date | Jun 19, 1985 |
At a glance
- 1–9 Supplements
- Jul 9, 1998 Latest supplement decision
- Yes Withdrawn
- No Summary of safety and effectiveness on file
- None UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: