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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceMEDSTONE 1050 ECTRACORPOREAL SHOCK WAVE LITHOTRIPT
Generic NameLithotriptor, extracorporeal shock-wave, urological
Regulation Number876.5990
ApplicantMEDSTONE INTL., INC.
100 COLUMBIA, SUITE 100
ALISO VIEJO, CA 92656-4114
PMA NumberP870015
Date Received04/13/1987
Decision Date04/15/1988
Reclassified Date 09/08/2000
Product Code LNS 
Docket Number 88M-0186
Notice Date 06/07/1988
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination ProductNo
Supplements:  S001 S002 S003 S008 S009 S010 S012 S013 S015 S016 S017 
S018 S019 S020 S021 S022 S024 S025 S026 S027 S028 S029 S030 
S031 S033 S034 S035 S036 
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