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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMEDSTONE STS LITHOTRIPTER
Generic NameLithotripter, shockwave (for treating gallbladder stones)
ApplicantMEDSTONE INTL., INC.
100 COLUMBIA, SUITE 100
ALISO VIEJO, CA 92656-4114
PMA NumberP970042
Supplement NumberS002
Date Received02/21/2002
Decision Date08/20/2002
Withdrawal Date 02/10/2004
Product Code NCV 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
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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