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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) LITHOTRIPTER
Generic NameLithotriptor, extracorporeal shock-wave, urological
Regulation Number876.5990
ApplicantMedstone Intl., Inc.
100 Columbia, Suite 100
Aliso Viejo, CA 92656
PMA NumberP870015
Supplement NumberS025
Date Received10/11/1996
Decision Date11/18/1996
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  
USE OF THE PHYSICIAN'S REFERENCE GUIDE ENTITLED "PHYSICIAN'S REFERENCE GUIDE FOR THE MEDSTONE STS(R) SHOCK WAVE THERAPY SYSTEM"
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