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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 1050 EXTRACORPOREAL 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
Supplement NumberS009
Date Received06/20/1990
Decision Date02/06/1991
Reclassified Date 09/08/2000
Product Code LNS 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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