PMA supplement
P160053 S002: MagtraceTM and Sentimag(R) Magnetic Locatization System
FDA PMA supplement · Panel Track · Endomagnetics Ltd.,
Key facts
| Original PMA | P160053 |
|---|---|
| Supplement number | S002 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | MagtraceTM and Sentimag(R) Magnetic Locatization System |
| Generic name | Lymph node location system during sentinel biopsy procedure |
| Applicant | Endomagnetics Ltd., |
| Product code | PUV |
| Received date | Aug 30, 2018 |
| Decision date | Dec 6, 2022 |
| Docket number | 22M-3128 |
| Notice date | Dec 8, 2022 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: