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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.
 
DeviceECONOLITH(TM) LITHOTRIPTER
Generic NameLithotriptor, extracorporeal shock-wave, urological
Regulation Number876.5990
ApplicantMEDISPEC, LTD.
19110 MONTGOMERY VILLAGE AVE.
SUITE 100
MONTGOMERY VILLAGE, MD 20886
PMA NumberP950043
Date Received12/26/1995
Decision Date04/07/1997
Reclassified Date 09/08/2000
Product Code LNS 
Docket Number 97M-0253
Notice Date 07/10/1997
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ECONLITH(TM) EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER. THE DEVICE IS INDICATED FOR USE IN THE NON-INVASIVE FRAGMENTATION OF UPPER URINARY TRACT STONES BETWEEN 5 AND 20MM IN SIZE
Supplements:  S001 S002 S004 S005 S006 
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