PMA P160053S011
- Device
- Magtrace® and Sentimag® Magnetic Locatization System (PUV)
- Applicant
- Endomagnetics Ltd.,
- PMA number
- P160053
- Supplement
- S011
- Product code
- PUV
- Decision date
- 2024-07-03
- Classification
- General, Plastic Surgery
- Generic name
- Lymph node location system during sentinel biopsy procedure
- Approval order statement
- Post-Approval Study (2ml) is placed on hold.
Current openFDA PMA Record#
- Device
- Magtrace® and Sentimag® Magnetic Locatization System (PUV)
- Applicant
- Endomagnetics Ltd.,
- PMA number
- P160053
- Supplement
- S011
- Product code
- PUV
- Generic name
- Lymph node location system during sentinel biopsy procedure
- Decision date
- 2024-07-03
- Decision code
- APPR
- Date received
- 2024-06-10
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Post-Approval Study (2ml) is placed on hold.