- Device
- MagtraceTM and Sentimag(R) Magnetic Locatization System
- Applicant
- Endomagnetics Ltd.,
- PMA number
- P160053
- Supplement
- S005
- Product code
- PUV
- Generic name
- Lymph node location system during sentinel biopsy procedure
- Decision date
- 2022-09-13
- Decision code
- APPR
- Date received
- 2022-03-24
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approved for using new Gen 3 and Gen 3T Sentimag detectors to detect Magtrace, addition of CIDEX OPA as a high level disinfectant for disinfecting Sentimag Gen 3 and Gen 3T detectors, and addition of certain low temperature sterilization systems for certain cycles for sterilization of Sentimag Gen 3 and Gen 3T detectors.