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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 LITHOTRIPTER
Classification Namelithotriptor, extracorporeal shock-wave,urological
Generic Nameextracorporeal shock wave lithotripter
Regulation Number876.5990
ApplicantMEDISPEC, LTD.
PMA NumberP950043
Supplement NumberS006
Date Received05/19/1999
Decision Date08/27/1999
Product Code
LNS[ Registered Establishments with LNS ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason pas protocal supplement ode/oir
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the final report of the postapproval study regarding the possible relationship between extracorporeal shcok wave lithotripsy and the onset of hypertension, and 2) modifications tothe econolith(tm) lithotripter's labeling to reflect the results of the final report. Based upon the information submitted, fda believes that the postapproval report demonstrates that hypertension is not a long-term risk of extracorporeal shock wave lithotripsy, and that the postapproval requirement is now complete.
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