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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namelithotripter, shockwave (for treating gallbladder stones)
Generic Namelithotripter, shockwave (for treating gallbladder stones)
100 columbia, suite 100
aliso viejo, CA 92656-4114
PMA NumberP970042
Supplement NumberS003
Date Received07/03/2002
Decision Date02/14/2003
Product Code
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the sts-tc/u lithotripter (transportable version of the sts lithotripter with ultrasound). The device, as modified, will be marketed under the trade name medstone sts-tc/u lithotripter and is indicated for 1) the fragmentation of symptomatic upper urinary tract stones, i. E. , renal calyceal stones, renal pelvic stones, and upper ureteral stones, and 2) when used in conjunction with certain ursodiols, is indicated for the treatment of symptomatic, solitary, radiolucent, non-calcified gallstones (between 4 and 20 mm in maximum diameter) in adult 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.