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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.
Classification Namelithotriptor, extracorporeal shock-wave,urological
Generic Nameextracorporeal shock wave lithotripter
Regulation Number876.5990
PMA NumberP950043
Date Received12/26/1995
Decision Date04/07/1997
Reclassified Date 09/08/2000
Product Code
LNS[ Registered Establishments with LNS ]
Docket Number 97M-0253
Notice Date 07/10/1997
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination Product No
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