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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 LITHOTRIPTER
Classification Namelithotriptor, extracorporeal shock-wave,urological
Generic Namelithotripter
Regulation Number876.5990
ApplicantMEDSTONE INTL., INC.
PMA NumberP870015
Supplement NumberS033
Date Received06/14/1999
Decision Date06/21/1999
Product Code
LNS[ Registered Establishments with LNS ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for use of an alternate ecg monitor, minor software upgrades to version 1999. 2, and associated changes to the device labeling.
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