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TPLC - Total Product Life Cycle

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Device neurovascular mechanical thrombectomy device for acute ischemic stroke treatment
Definition A neurovascular mechanical thrombectomy device for acute ischemic stroke treatment is a prescription device used in the treatment of acute ischemic stroke to improve clinical outcomes. The device is delivered into the neurovasculature with an endovascular approach, mechanically removes thrombus from the body, and restores blood flow in the neurovasculature.
Product CodePOL
Regulation Number 882.5600
Device Class 2


Premarket Reviews
ManufacturerDecision
CONCENTRIC MEDICAL, INC.
  GRANTED 1

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