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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device vaginal hydrogel packing system
Definition A vaginal hydrogel packing system is a non-powered positioning device composed of a flexible container filled with a hydrogel. The device is intended to reduce the radiation dose delivered to adjacent pelvic organs by temporarily displacing the vaginal wall and adjacent pelvic tissues during radiation therapy treatment planning and delivery.
Product CodeQXR
Regulation Number 892.5735
Device Class 2


Premarket Reviews
ManufacturerDecision
BRACHYFOAM, INC. D/B/A ADVARAY
  GRANTED 1

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