PMA P160053S001
- Device
- MagtraceTM and Sentimag(R) Magnetic Locatization System
- Applicant
- Endomagnetics Ltd.,
- PMA number
- P160053
- Supplement
- S001
- Product code
- PUV
- Decision date
- 2019-05-08
- Classification
- Lymph Node Location System During Sentinel Biopsy Procedure
- Generic name
- Lymph node location system during sentinel biopsy procedure
- Approval order statement
- Approval for packaging Magtrace vials with new replacement stoppers (i.e., West 1358).
Current openFDA PMA Record#
- Device
- MagtraceTM and Sentimag(R) Magnetic Locatization System
- Applicant
- Endomagnetics Ltd.,
- PMA number
- P160053
- Supplement
- S001
- Product code
- PUV
- Generic name
- Lymph node location system during sentinel biopsy procedure
- Decision date
- 2019-05-08
- Decision code
- APPR
- Date received
- 2018-07-30
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for packaging Magtrace vials with new replacement stoppers (i.e., West 1358).