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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.
 
DeviceLITHOTRON ULS
Generic NameLithotriptor, extracorporeal shock-wave, urological
Regulation Number876.5990
ApplicantHealthtronics Surgical Services, Inc.
425 Franklin Rd., Suite 545
Marietta, GA 30067
PMA NumberP970019
Supplement NumberS006
Date Received07/06/1999
Decision Date12/17/1999
Reclassified Date09/08/2000
Product Code LNS 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for addition of an ultrasonic stone location accessory. The device is indicated for preliminary localization of a target stone prior to extracorporeal shock wave lithotripsy with the Lithotron(TM) Lithotripsy System. The indications for use have not changed.
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