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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.
 
DeviceHEALTHTRONICS LITHOTRON LIHTOTRIPSY 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 NumberS003
Date Received07/23/1998
Decision Date11/18/1998
Reclassified Date09/08/2000
Product Code LNS 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day 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 modifications to the LithoTron(TM) Lithotripsy System's labeling to reflect the results of this final report. Based upon the information submitted, FDA believes that the postapproval report demonstrates that hypertension is not a long-term risk of extracorporeal shock wave lithotripsy, and that this postapproval requirement is now considered complete.
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