MagtraceTM and Sentimag(R) Magnetic Locatization System
FDA premarket approval P160053/S002 · decided 2022-12-06
Approval details
- PMA number
- P160053
- Supplement
- S002
- Supplement type
- Panel Track
- Supplement reason
- 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.,
- Date received
- 2018-08-30
- Decision date
- 2022-12-06
- Days to decision
- 1559 days
- Decision code
- APPR
- Product code
- PUV
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Cambridge
- Statement
- Approved to assist in localizing lymph nodes draining a tumor site, as part of a sentinel lymph node biopsy procedure, in patients with breast cancer undergoing a mastectomy or lumpectomy. For patients undergoing lumpectomy, nipple sparing, nipple areolar sparing or skin sparing procedures, Magtrace is indicated to be injected only peritumorally.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Magseed Pro Magnetic Marker System (K232865) | Endomagnetics Ltd., | 2024-06-28 |
| Sentimag System (K222832) | Endomagnetics Ltd., | 2023-01-21 |
| Magseed Magnetic Marker Systtem (K173587) | Endomagnetics Ltd., | 2018-02-16 |
| Magseed Magnetic Marker System (K163541) | Endomagnetics Ltd., | 2017-01-13 |
| Sentimag System, Sentimark Magnetic Marker Systerm (K153044) | Endomagnetics Ltd., | 2016-03-02 |