Covidien gets FDA OK for changes to PTFE coating production process

Changes made by Covidien to its polytetrafluoroethylene coating production process have been approved by the FDA. The PTFE coating is used with the delivery wires of Covidien's Alligator and Pipeline systems, designed to treat brain aneurysms. Concerns that the coating could detach from the devices led the company to voluntarily recall certain lots of the products in April.

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Pharmaceutical Processing · Wall Street Journal (tiered subscription model), The

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