Magtrace and Sentimag Magnetic Locatization System (PUV)
FDA premarket approval P160053/S010 · decided 2024-06-07
Approval details
- PMA number
- P160053
- Supplement
- S010
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Magtrace and Sentimag Magnetic Locatization System (PUV)
- Generic name
- Lymph node location system during sentinel biopsy procedure
- Applicant
- Endomagnetics Ltd.,
- Date received
- 2024-05-14
- Decision date
- 2024-06-07
- Days to decision
- 24 days
- Decision code
- APPR
- Product code
- PUV
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Cambridge
- Statement
- Approval for the post-approval study 1 ml Magtrace w Sentimag PAS.
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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 |