PMA
P090012: MELAFIND
FDA PMA · Optical diagnostic device for melanoma detection · Strata Skin Sciences, Inc.
Key facts
| PMA number | P090012 |
|---|---|
| Trade name | MELAFIND |
| Generic name | Optical diagnostic device for melanoma detection |
| Applicant | Strata Skin Sciences, Inc. |
| Owner/operator | STRATA Skin Sciences, INC. |
| Product code | OYD |
| Approval date | Nov 1, 2011 |
| Docket number | 12M-0074 |
| Notice date | Jan 24, 2012 |
| Establishment registration | 2031934 |
| FEI number | 3002942014 |
At a glance
- 10–99 Supplements
- Aug 18, 2016 Latest supplement decision
- No Withdrawn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: