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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.
 
Trade NameMEDSTONE STS LITHOTRIPTER
Classification Namelithotriptor, extracorporeal shock-wave,urological
Regulation Number876.5990
ApplicantMEDSTONE INTL., INC.
PMA NumberP970042
Supplement NumberS002
Date Received02/21/2002
Decision Date08/20/2002
Product Code
LNS[ Registered Establishments with LNS ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
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.
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