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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements 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
Date Received09/04/1997
Decision Date09/05/2000
Withdrawal Date 02/10/2004
Product Code
Docket Number 00M-1515
Notice Date 09/15/2000
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the medstone sts(tm) lithotripter in conjunction with actgall(r). When used with the drug, this device 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 actigall(r) (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 actigall(r) until a stone-free state is achieved.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S004