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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 92656-4114
PMA NumberP870015
Supplement NumberS029
Date Received03/24/1998
Decision Date03/27/1998
Reclassified Date 09/08/2000
Product Code LNS 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for modification of the Medstone STS(TM) Lithotripter to include an alternate model x-ray generator (i.e., the Creos XHF-30-ESU).
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