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Home » FDA clears St. Jude’s Amplatzer catheter-based vascular plug | Regulatory Roundup

FDA clears St. Jude’s Amplatzer catheter-based vascular plug | Regulatory Roundup

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MassDevice.com Regulatory Roundup

 St. Jude lands FDA OK for transcatheter vascular plug
St. Jude Medical (NYSE:STJ) won FDA 510(k) clearance for its next-generation Amplatzer vascular plug 4, which the company calls the "industry’s first vascular plug that can be delivered using a standard diagnostic catheter."

The device, which has had CE Mark approval in the European Union since 2009, allows physicians to quickly block or redirect blood flow by closing abnormal blood vessels.
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 LensAR touts FDA clearance for cataract surgery system
Orlando, Fla.-based LensAR Inc. won FDA clearance for its next-generation LensAR laser system for cataract surgery, which is in preparation for commercial launch in the U.S.
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 Sigma expands Spectrum infusion pump recall

Sigma International expanded its infusion pump recall, initiated July 2011, to include additional pumps manufactured between Jan. 18, 2005, and Nov. 1, 2010, over concerns that they may suddenly fail and cause either back-flow or overflow without issuing an alarm.  
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