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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.
 
DeviceDORNIER COMPACT S) AND DORNIER LITHOTRIPTER (STATIONARY & TRANSPORTABLE
Generic NameLithotriptor, extracorporeal shock-wave, urological
Regulation Number876.5990
ApplicantDornier Medtech America, Inc.
1155 Roberts Blvd.
Kennesaw, GA 30144
PMA NumberP840008
Supplement NumberS058
Date Received12/09/1996
Decision Date05/05/1997
Reclassified Date09/08/2000
Product Code LNS 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A NON-ECG SHOCK WAVE TRIGGER MODE FOR THE DORNIER COMPACT S AND THE MOVE AND SHOOT FEATURE FOR THE DORNIER LITHOTRIPTER (STATIONARY AND TRANSPORTABLE).
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