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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 NameMODEL MFL5000 EXPANSION OF INDICATION RANGE
Classification Namelithotriptor, extracorporeal shock-wave,urological
Generic Nameextracorporeal shock-wave lithotriptor
Regulation Number876.5990
ApplicantDORNIER MEDTECH AMERICA, INC.
PMA NumberP840008
Supplement NumberS040
Date Received05/11/1992
Decision Date03/08/1993
Product Code
LNS[ Registered Establishments with LNS ]
Docket Number 93M-0124
Advisory Committee Gastroenterology/Urology
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
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