MagtraceTM and Sentimag(R) Magnetic Locatization System
FDA premarket approval P160053/S001 · decided 2019-05-08
Approval details
- PMA number
- P160053
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MagtraceTM and Sentimag(R) Magnetic Locatization System
- Generic name
- Lymph node location system during sentinel biopsy procedure
- Applicant
- Endomagnetics Ltd.,
- Date received
- 2018-07-30
- Decision date
- 2019-05-08
- Days to decision
- 282 days
- Decision code
- APPR
- Product code
- PUV
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Cambridge
- Statement
- Approval for packaging Magtrace vials with new replacement stoppers (i.e., West 1358).
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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 |