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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


Premarket Reviews
ManufacturerDecision
DXTX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1 1

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