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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.
 
DeviceMODULARIS LITHO
Generic NameLithotriptor, extracorporeal shock-wave, urological
Regulation Number876.5990
ApplicantSIEMENS CORP.
186 WOOD AVE., SOUTH
ISELIN, NJ 08830
PMA NumberP870018
Supplement NumberS021
Date Received05/01/1998
Decision Date09/21/1998
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 a compact transportable (within the hospital only) configuration of the Lithostar(R) Shock Wave System C. The device, as modified, will be marketed under the trade name Lithostar(R) Modularis and is indicated for use in the fragmentation of urinary tract stones, i.e., renal calyceal stones, renal pelvic stones, and upper ureteral stones.
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