DevicePMAs@therightstef:P810002_S058 JSONTXT

Approval for an additional configuration of the aortic valved graft using the sjm masters series aortic valved prosthesis with the vascutek gelweave valsalva graft. The device, as modified, will be marketed under the trade name sjm masters series aortic valved prosthesis with vascutek gelweave valsalva graft (model vavgj-515) and is indicated for the replacement of a malfunctioning native or prosthetic aortic heart valve and ascending aorta.