PMA
P150046: NEVISENSE
FDA PMA · Electrical Impedance Spectrometer · Scibase AB
Key facts
| PMA number | P150046 |
|---|---|
| Trade name | NEVISENSE |
| Generic name | Electrical Impedance Spectrometer |
| Applicant | Scibase AB |
| Owner/operator | Scibase AB |
| Product code | ONV |
| Approval date | Jun 28, 2017 |
| Docket number | 17M-3982 |
| Notice date | Jun 30, 2017 |
| Establishment registration | 3008285458 |
| FEI number | 3008285458 |
At a glance
- 1–9 Supplements
- Feb 26, 2026 Latest supplement decision
- No Withdrawn
- Yes 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: