Cook Medical Reintroduces Its Evolution® RL Lead Extraction Products To The United States Market

VANDERGRIFT, Pa.--(BUSINESS WIRE)--Effective immediately, Cook Medical customers in the United States will again have access to its Evolution® RL and Evolution® Shortie RL Controlled-Rotation Dilator Sheath Sets. Distribution of these products within the U.S. market was suspended for two months while Cook’s Lead Management clinical division worked with the U.S. Food and Drug Administration (FDA) to resolve agency questions about the marketing clearance of these products. The devices, which remained available in Europe and other markets, were not recalled by FDA.

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