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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 NumberS034
Date Received11/16/1999
Decision Date11/19/1999
Product Code
LNS[ Registered Establishments with LNS ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for minor changes to the hardware (i. E. , modification to the remote control, addition of a foot switch, increase in the travel distance of the shockwave positionere, and modification to the printed circuit board that interfaces the computer with the axis controllers) and software (i. E. , upgrade to version 1999. 3), as well as minor changes tot he device's labeling.
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