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U.S. Department of Health and Human Services

Product Classification
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Device low electric field generator for pancreatic cancer treatment
Definition Intended to treat pancreatic cancer through delivery of low electric fields in patients receiving concomitant systemic therapies or other standard of care treatment(s)
Physical State Comprised of an electric field generator and insulated transducer arrays.
Technical Method Transducer arrays are placed on the patient’s abdomen which produce alternating electrical fields within the body. These electrical fields physically disrupt the rapid cell division of cancer cells.
Target Area Abdomen/Pancreas
Review Panel General & Plastic Surgery
Product CodeSHC
Premarket Review General Surgery Devices (DHT4A)
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		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible
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