PMA
P160053: MagtraceTM and Sentimag(R) Magnetic Locatization System
FDA PMA · Lymph node location system during sentinel biopsy procedure · Endomagnetics Ltd.,
Key facts
| PMA number | P160053 |
|---|---|
| Trade name | MagtraceTM and Sentimag(R) Magnetic Locatization System |
| Generic name | Lymph node location system during sentinel biopsy procedure |
| Applicant | Endomagnetics Ltd., |
| Owner/operator | HOLOGIC, INC. |
| Product code | PUV |
| Approval date | Jul 24, 2018 |
| Docket number | 18M-2887 |
| Notice date | Jun 29, 2018 |
| Establishment registration | 3012644426 |
| FEI number | 3012644426 |
At a glance
- 10–99 Supplements
- May 18, 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- No Withdrawn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: