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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.
 
DeviceMOBILE LITHOSTAR WITH SHOCK WAVE SYSTEM C (SWSC)
Classification Namelithotriptor, extracorporeal shock-wave,urological
Generic Namelithotriptor, extracorporeal shock-wave,urological
Regulation Number876.5990
Applicant
SIEMENS CORP.
186 wood ave., south
iselin, NJ 08830
PMA NumberP870018
Supplement NumberS015
Date Received04/11/1996
Decision Date06/05/1996
Product Code
LNS[ Registered Establishments with LNS ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A MOBILE VERSION OF THE LITHOSTAR SHOCK WAVE SYSTEM C. THE DEVICE AS MODIFIED, WILL BE MARKEDTED UNDER THE TRADE NAME MOBILE LITHOSTAR SHOCK WAVE SYSTEM C
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