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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 SHOCK WAVE SYSTEM C
Generic NameLithotriptor, extracorporeal shock-wave, urological
Regulation Number876.5990
ApplicantSIEMENS CORP.
186 WOOD AVE., SOUTH
ISELIN, NJ 08830
PMA NumberP870018
Supplement NumberS011
Date Received09/05/1995
Decision Date03/01/1996
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
Approval Order Statement  
APPROVAL FOR MODIFICATIONS MADE TO THE SHOCK TUBE, WATER CONDITIONING SYSTEM, SHOCK WAVE GENERATOR, SHOCK WAVE ENERGY SETTING, AND LABELING. THE DEVICE AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LITHOSTAR SHOCK WAVE SYSTEM C
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