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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) EXTRACORPOREAL SHOCK WAVE LITHOTR
Classification Namelithotriptor, extracorporeal shock-wave,urological
Generic Nameshock wave lithotripter
Regulation Number876.5990
ApplicantMEDSTONE INTL., INC.
PMA NumberP870015
Supplement NumberS021
Date Received07/13/1995
Decision Date09/15/1995
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 the following modifications:use of alternate ultrasound imaging unit; use of alternate digitizer pad; modification of system software to version 7. 10; and revisions to systems user's manual.
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