Resources for Food and Drug Administration (FDA)
AngioScore catheter gets FDA approval
www.bizjournals.com The Food and Drug Administration approved for marketing AngioScore Inc.'s balloon catheter device, the company said Thursday.
Fremont-based AngioScore, which develops angioplasty catheters for use in the treatment of cardiovascular disease, said the FDA cleared the device for balloon dilatation of lesions in the iliac, femoral, ilio-femoral, popliteal, and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The catheter received initial FDA 510(k) clearance for the treatment of infra-popliteal peripheral arterial disease in September 2005.
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