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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.
 
DeviceTRANSPORTABLE MODEL STS-T LITHOTRIPTER
Generic NameLithotriptor, extracorporeal shock-wave, urological
Regulation Number876.5990
ApplicantMedstone Intl., Inc.
100 Columbia, Suite 100
Aliso Viejo, CA 92656
PMA NumberP870015
Supplement NumberS035
Date Received02/15/2000
Decision Date02/25/2000
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 (1) minor changes to the labeling to minimize the risk of electrical shock from the U-arm, and (2) the additon of protective covers for the U-arm's electrical connections.
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