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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
Classification Namelithotriptor, extracorporeal shock-wave,urological
Generic Nameextracorporeal shock wave ltthrtripsy (eswl)
Regulation Number876.5990
ApplicantSIEMENS CORP.
PMA NumberP870018
Supplement NumberS016
Date Received05/20/1996
Decision Date06/21/1996
Product Code
LNS[ Registered Establishments with LNS ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifying your user's manual. The device, as modified, will be marketed under the trade name lithostar.
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