Premarket Approval (PMA)

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.

• Trade Name: MEDSTONE STS LITHOTRIPTER
• Classification Name: lithotripter, shockwave (for treating gallbladder stones)
• Generic Name: extracorporeal shock wave lithotripsy device
• Applicant: MEDSTONE INTL., INC.
• PMA Number: P970042
• Date Received: 09/04/1997
• Decision Date: 09/05/2000
• Withdrawal Date: 02/10/2004
• Product Code: NCV
• Docket Number: 00M-1515
• Notice Date: 09/15/2000
• Advisory Committee: Gastroenterology/Urology
• Expedited Review Granted?: No
• Combination Product: No
• Information About: Labeling, Approval Order, Summary of Safety and Effectiveness

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

• Supplements: S001 S002 S003 S004