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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-TC/U LITHOTRIPTER
Classification Namelithotripter, shockwave (for treating gallbladder stones)
Generic Namelithotripter, shockwave (for treating gallbladder stones)
Applicant
MEDSTONE INTL., INC.
100 columbia, suite 100
aliso viejo, CA 92656-4114
PMA NumberP970042
Supplement NumberS003
Date Received07/03/2002
Decision Date02/14/2003
Product Code
NCV
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.
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