PMA
P170039: CustomFlex Artificial Iris
FDA PMA · Artificial iris · Humanoptics AG
Key facts
| PMA number | P170039 |
|---|---|
| Trade name | CustomFlex Artificial Iris |
| Generic name | Artificial iris |
| Applicant | Humanoptics AG |
| Owner/operator | HumanOptics Holding AG |
| Product code | QBT |
| Approval date | May 30, 2018 |
| Establishment registration | 3010531293 |
| FEI number | 3010531293 |
At a glance
- 1–9 Supplements
- Sep 4, 2020 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 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: