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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-T TRANSPORTABLE LITHOTRIPTER
Classification Namelithotriptor, extracorporeal shock-wave,urological
Generic Nameshock wave lithotripter
Regulation Number876.5990
ApplicantMEDSTONE INTL., INC.
PMA NumberP870015
Supplement NumberS030
Date Received07/17/1998
Decision Date09/16/1998
Product Code
LNS[ Registered Establishments with LNS ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a transportable configuration of the medstone sts lithotripter. The devices, as modified, will be marketed under the trade name medstone sts-t transportable lithotripter and is indicated for use in fragmentation of upper urinary tract stones, i. E. , renal calyceal stones, renal pelvic stones, and upper ureteral stones.
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