PMA P160053S012

Device: MagtraceTM and Sentimag(R) Magnetic Locatization System
Applicant: Endomagnetics Ltd.,
PMA number: P160053
Supplement: S012
Product code: PUV
Decision date: 2026-05-18
Classification: General, Plastic Surgery
Generic name: Lymph node location system during sentinel biopsy procedure
Approval order statement: approval for the generation of a new UDI and reference number for Magtrace products sold specifically in the United States to satisfy traceability and UDI requirements

Current openFDA PMA Record#

Device: MagtraceTM and Sentimag(R) Magnetic Locatization System
Applicant: Endomagnetics Ltd.,
PMA number: P160053
Supplement: S012
Product code: PUV
Generic name: Lymph node location system during sentinel biopsy procedure
Decision date: 2026-05-18
Decision code: OK30
Date received: 2026-03-17
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for the generation of a new UDI and reference number for Magtrace products sold specifically in the United States to satisfy traceability and UDI requirements