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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameMEDSTONE 1050 ECTRACORPOREAL SHOCK WAVE LITHOTRIPT
Classification Namelithotriptor, extracorporeal shock-wave,urological
Generic Nameshock wave lithotripter
Regulation Number876.5990
ApplicantMEDSTONE INTL., INC.
PMA NumberP870015
Date Received04/13/1987
Decision Date04/15/1988
Reclassified Date 09/08/2000
Product Code
LNS[ Registered Establishments with LNS ]
Docket Number 88M-0186
Notice Date 06/07/1988
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination Product No
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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