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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 NumberS021
Date Received07/13/1995
Decision Date09/15/1995
Reclassified Date09/08/2000
Product Code LNS 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE FOLLOWING MODIFICATIONS:USE OF ALTERNATE ULTRASOUND IMAGING UNIT; USE OF ALTERNATE DIGITIZER PAD; MODIFICATION OF SYSTEM SOFTWARE TO VERSION 7.10; AND REVISIONS TO SYSTEMS USER'S MANUAL
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