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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.
 
DeviceLITHO TRON LITHOTRIPSY SYSTEM
Generic NameLithotriptor, extracorporeal shock-wave, urological
Regulation Number876.5990
ApplicantHealthtronics Surgical Services, Inc.
425 Franklin Rd., Suite 545
Marietta, GA 30067
PMA NumberP970019
Supplement NumberS005
Date Received11/12/1998
Decision Date11/17/1998
Reclassified Date09/08/2000
Product Code LNS 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for use of a new patient table model with the LithoTron(TM) Lithotripsy System, with associated labeling changes.
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