PMA
N18143: PREFLEX AND FLEXCARE SOL.
FDA PMA · Accessories, soft lens products · Alcon Laboratories
Key facts
| PMA number | N18143 |
|---|---|
| Trade name | PREFLEX AND FLEXCARE SOL. |
| Generic name | Accessories, soft lens products |
| Applicant | Alcon Laboratories |
| Owner/operator | Alcon Laboratories, Inc. |
| Product code | LPN |
| Approval date | Apr 26, 1982 |
| Notice date | Jun 15, 1979 |
| Establishment registration | 1610287 |
| FEI number | 1610287 |
At a glance
- 10–99 Supplements
- Feb 10, 1997 Latest supplement decision
- Yes Withdrawn
- No Summary of safety and effectiveness on file
- 1–9 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: