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U.S. Department of Health and Human Services

Product Classification

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Device lymph node location system during sentinel biopsy procedure
Definition Locating lymph nodes draining a tumor as part of the sentinel lymph node biopsy procedure
Physical State The solution is considered a combination product. The iron particle is surrounded by a carboxydextran coating. The carboxydextran coating is considered a drug. The nanoparticles are then mixed in a saline solution. The system uses an electronic base device with a magnetic probe.
Technical Method The solution is composed of iron nanoparticles which is injected peri-tumor. The nanoparticles are taken up by the lymphatic system and remains there. The magnetic probe is used to locate the iron nanoparticles which should collect in the lymph nodes.
Target Area Cancer tumor
Review Panel General & Plastic Surgery
Product CodePUV
Premarket Review Surgical and Infection Control Devices (OHT4)
General Surgery Devices (DHT4A)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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