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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device peripheral temporary and retrievable stent system
Definition A peripheral temporary and retrievable stent system is a temporary scaffold placed into the peripheral vasculature via a delivery catheter system for treating stenotic lesions. The device is designed to be retrieved and removed following successful treatment.
Product CodeSEU
Regulation Number 870.5110
Device Class 2


Premarket Reviews
ManufacturerDecision
REFLOW MEDICAL, INC.
  GRANTED 1

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