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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 CORP.
PMA NumberP870018
Supplement NumberS017
Date Received06/17/1997
Decision Date08/26/1998
Product Code
LNS[ Registered Establishments with LNS ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new configuration of the lithostar(r). The device, as modified, will be marketed under the trade name lithostar(r) multiline and is indicated for use in patients with renal and upper ureteral caculi between 5mm and 15mm.
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