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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.
 
DeviceLITHOSTAR MULTILINE
Generic NameLithotriptor, extracorporeal shock-wave, urological
Regulation Number876.5990
ApplicantSiemens Corp.
186 Wood Ave. S.
Iselin, NJ 08830
PMA NumberP870018
Supplement NumberS019
Date Received12/11/1997
Decision Date12/29/1997
Reclassified Date09/08/2000
Product Code LNS 
Advisory Committee Gastroenterology/Urology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for revision of the labeling regarding the risk of hypertension following renal lithotripsy (consistent with the conclusions of your final postapproval study report).
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