PMA
P040028: LUMA CERVICAL IMAGING SYSTEM
FDA PMA · Sensor, electro-optical (for cervical cancer) · Spectra Science
Key facts
| PMA number | P040028 |
|---|---|
| Trade name | LUMA CERVICAL IMAGING SYSTEM |
| Generic name | Sensor, electro-optical (for cervical cancer) |
| Applicant | Spectra Science |
| Product code | MWM |
| Approval date | Mar 16, 2006 |
| Docket number | 06M-0148 |
| Notice date | Apr 12, 2006 |
At a glance
- 1–9 Supplements
- Mar 19, 2009 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- Yes Withdrawn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: