FDAnews Device Daily Bulletin

ANGIOTECH ANNOUNCES VASCULAR WRAP/LIFESPAN VASCULAR GRAFT COMBINATION PRODUCT RECEIVES DESIGNATION OF 'DEVICE' FOR U.S. PIVOTAL STUDY

Dec. 21, 2005
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Angiotech Pharmaceuticals, Inc. today announced that its Vascular Wrap Paclitaxel-Eluting Mesh/Lifespan Vascular Graft has received a designation of "device" from the Office of Combination Products at the U.S. Food and Drug Administration (FDA). This designation of "device" has historically indicated a faster regulatory and commercial timeline for a product as compared to when the FDA considers a combination product to be a "drug".

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