FDAnews Device Daily Bulletin

FDA CLEARS BAXTER'S AMICUS FOR SEVEN-DAY STORAGE OF PLATELETS

Nov. 21, 2005
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The FDA has granted 510(k) clearance for the seven-day storage of a type of blood platelets collected on Baxter Healthcare's Amicus Separator and stored in Baxter's PL 2410 collection container.

"Extending the shelf life for platelets collected on Baxter's Amicus Separator will help to assure that an adequate supply of high-quality platelets are available for patients in need," said Kevin McCulloch, general manager for Baxter's Transfusion Therapies business. "We will be working closely with blood centers around the country to ensure that implementation of seven-day platelets meets all expectations and requirements."

Baxter said it would conduct an extensive postmarket surveillance study to comply with ongoing evaluation requirements. Individual blood centers wishing to secure licensure for platelets collected on the Amicus Separator and stored in Baxter's PL 2410 plastic container for up to seven days will be required to work with the FDA to obtain individual center approval, Baxter said.

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