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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceLITHOSTAR CHANGES TO SETTING AND MONITOR
Generic NameLithotriptor, extracorporeal shock-wave, urological
Regulation Number876.5990
ApplicantSIEMENS CORP.
186 WOOD AVE., SOUTH
ISELIN, NJ 08830
PMA NumberP870018
Supplement NumberS007
Date Received06/17/1992
Decision Date10/05/1992
Reclassified Date 09/08/2000
Product Code LNS 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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