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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameECONOLITH(TM) LITHOTRIPTER
Classification Namelithotriptor, extracorporeal shock-wave,urological
Generic Nameextracorporeal shock wave lithotripter
Regulation Number876.5990
ApplicantMEDISPEC, LTD.
PMA NumberP950043
Supplement NumberS002
Date Received04/06/1998
Decision Date05/05/1998
Product Code
LNS[ Registered Establishments with LNS ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for non-synchronized eswl, addition of a ecg simulator/adapter, and appropriate labeling revisions.
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