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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameLITHOSTAR MULTILINE
Classification Namelithotriptor, extracorporeal shock-wave,urological
Generic Nameextracorporeal shock wave ltthrtripsy (eswl)
Regulation Number876.5990
ApplicantSIEMENS MEDICAL SOLUTIONS USA, INC.
PMA NumberP870018
Supplement NumberS023
Date Received02/12/1999
Decision Date04/30/1999
Product Code
LNS[ Registered Establishments with LNS ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at siemens ag, roentgenstrasse 19-21, kemnath, germany. Final assembly and system testing of the lithostar multiline will be performed at this facility.
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