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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 NumberS001
Date Received06/25/1997
Decision Date06/30/1997
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 a transportable version of the econolith(tm) lithotripter.
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