PMA
P120023: KAMRA INLAY
FDA PMA · Implant, corneal, refractive · Corneagen
Key facts
| PMA number | P120023 |
|---|---|
| Trade name | KAMRA INLAY |
| Generic name | Implant, corneal, refractive |
| Applicant | Corneagen |
| Owner/operator | CorneaGen |
| Product code | LQE |
| Approval date | Apr 17, 2015 |
| Docket number | 15M-1326 |
| Notice date | Apr 29, 2015 |
| Establishment registration | 3005357288 |
| FEI number | 3005357288 |
At a glance
- 1–9 Supplements
- Jul 18, 2017 Latest supplement decision
- Yes Withdrawn
- Yes 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: