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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(TM) LITHOTRIPTER
Classification Namelithotriptor, extracorporeal shock-wave,urological
Generic Nameshock wave lithotripter
Regulation Number876.5990
ApplicantMEDSTONE INTL., INC.
PMA NumberP870015
Supplement NumberS025
Date Received10/11/1996
Decision Date11/18/1996
Product Code
LNS[ Registered Establishments with LNS ]
Advisory Committee Gastroenterology/Urology
Supplement Type Special Supplement
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Use of the physician's reference guide entitled "physician's reference guide for the medstone sts(r) shock wave therapy system".
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