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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
Generic NameLithotriptor, extracorporeal shock-wave, urological
Regulation Number876.5990
ApplicantSiemens Corp.
186 Wood Ave. S.
Iselin, NJ 08830
PMA NumberP870018
Supplement NumberS013
Date Received02/23/1996
Decision Date03/13/1996
Reclassified Date09/08/2000
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS MADE TO THE ZOOM FUNCTION AND LABELING
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