Smith & Nephew PLC announced June 23 that it has temporarily ceased distributing Renasys negative pressure wound therapy products in the U.S. after FDA told the company that it requires 510(k) clearances for modifications the company made to the systems without regulatory approval.
Smith & Nephew said it has already filed 510(k)s with FDA for these modifications, which include enhancements to both Renasys pumps and consumables including improvements to the system’s soft port.
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