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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device agents, embolic, for treatment of benign prostatic hyperplasia
Definition The device comprises one or more objects placed in a blood vessel to permanently obstruct blood flow to the prostate to treat benign prostatic hyperplasia (BPH).
Product CodeNOY
Regulation Number 876.5550
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOSPHERE MEDICAL, INC.
  GRANTED 1

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