PMA
N17397: ACEPTOPLAST CONTACT LENS
FDA PMA · Alcon Laboratories, Inc.
Key facts
| PMA number | N17397 |
|---|---|
| Trade name | ACEPTOPLAST CONTACT LENS |
| Applicant | Alcon Laboratories, Inc. |
| Owner/operator | Alcon Laboratories, Inc. |
| Approval date | May 28, 1976 |
| Establishment registration | 1610287 |
| FEI number | 1610287 |
At a glance
- None Supplements
- May 28, 1976 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- Yes Withdrawn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: