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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMODEL MFL5000 EXPANSION OF INDICATION RANGE
Classification Namelithotriptor, extracorporeal shock-wave,urological
Generic Namelithotriptor, extracorporeal shock-wave,urological
Regulation Number876.5990
Applicant
Dornier MedTech America, Inc.
1155 roberts blvd.
kennesaw, GA 30144
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/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
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