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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prostate immobilizer rectal balloon
Definition Intended to be used for the temporary positioning of the rectal wall and adjacent structure in the male human anatomies. The purpose is to stabilize the prostate during computed tomography (CT) exam, X-ray, or radiation therapy (RT) treatments. The placement of the balloon requires a physician or a physician-directed healthcare professional, and is performed as a separate procedure apart from the standard CT exam and RT treatment.
Product CodePCT
Regulation Number 892.5720
Device Class 2