DevicePMAs@therightstef:P970042_S002 JSONTXT 13 Projects

Approval for 1) the use of two generic ursodiols, one manufactured by amide pharmaceutical and one by teva pharmaceutical, in addition to actigall; 2) a change in the post-approval study's medical monitor to joan l. drucker m. d., r. s. i.; and 3) several minor clarifications, corrections and editorial changes to the post-approval study protocol. The device, as modified, will be marketed under the same trade name, medstone sts lithotripter, and is indicated for the treatment of symptomatic, solitary, radiolucent, non-calcified gallstones (between 4 and 20 mm in maximum diameter) in adults patients for whom surgical removal of the gallbladder is medically contraindicated and in symptomatic high-risk patients who have actively refused surgery. Combination therapy consists of 1)administration of novartis pharmaceutical actigall, or amide pharmaceutical ursodiol, or teva pharmaceutical ursodiol (8-10 mg/kg/day) for at least two weeks pre-lithotripsy, 2) lithotripsy treatments of up to 2000 24 kv shocks, and 3) continued administration of ursodiol until a stone-free state is achieved.