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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.
 
DeviceMEDSTONE STS(TM) EXTRACORPOREAL SHOCK WAVE LITHOTR
Generic NameLithotriptor, extracorporeal shock-wave, urological
Regulation Number876.5990
ApplicantMedstone Intl., Inc.
100 Columbia, Suite 100
Aliso Viejo, CA 92656
PMA NumberP870015
Supplement NumberS024
Date Received04/22/1996
Decision Date05/24/1996
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 OT THE "PRECAUTIONS" SECTION OF THE USER'S MANUAL
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