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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 NameTRANSPORTABLE MODEL STS-T LITHOTRIPTER
Classification Namelithotriptor, extracorporeal shock-wave,urological
Generic Namelithotripter
Regulation Number876.5990
ApplicantMEDSTONE INTL., INC.
PMA NumberP870015
Supplement NumberS035
Date Received02/15/2000
Decision Date02/25/2000
Product Code
LNS[ Registered Establishments with LNS ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for (1) minor changes to the labeling to minimize the risk of electrical shock from the u-arm, and (2) the additon of protective covers for the u-arm's electrical connections.
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