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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 NameMFL5000 & DORNIER LITHOTRIPTERS (STATIOINARY & TRANSPORTABLE)
Classification Namelithotriptor, extracorporeal shock-wave,urological
Generic Nameextracorporeal shock-wave lithotriptor
Regulation Number876.5990
ApplicantDORNIER MEDTECH AMERICA, INC.
PMA NumberP840008
Supplement NumberS057
Date Received11/01/1996
Decision Date04/29/1997
Product Code
LNS[ Registered Establishments with LNS ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for non-ecg shock wave trigger modes for the above devices.
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