PMA P160053S007
- Device
- Magtrace® and Sentimag® Magnetic Locatization System (PUV)
- Applicant
- Endomagnetics Ltd.,
- PMA number
- P160053
- Supplement
- S007
- Product code
- PUV
- Decision date
- 2023-06-29
- Classification
- General, Plastic Surgery
- Generic name
- Lymph node location system during sentinel biopsy procedure
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- Magtrace® and Sentimag® Magnetic Locatization System (PUV)
- Applicant
- Endomagnetics Ltd.,
- PMA number
- P160053
- Supplement
- S007
- Product code
- PUV
- Generic name
- Lymph node location system during sentinel biopsy procedure
- Decision date
- 2023-06-29
- Decision code
- APPR
- Date received
- 2023-01-05
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.