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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 LITHOTRIPTER AND DORNIER LITHOTRIPTER TRANSPORTABLE
Generic NameLithotriptor, extracorporeal shock-wave, urological
Regulation Number876.5990
ApplicantDornier Medtech America, Inc.
1155 Roberts Blvd.
Kennesaw, GA 30144
PMA NumberP840008
Supplement NumberS054
Date Received03/22/1996
Decision Date10/08/1996
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 (I) A PATIENT AUTOMATIC POSITIONING FEATURE, (II) PATIENT DATA MANAGMENT SOFTWARE, (III) THE PERFORMA ULTRASOUND SYSTE, AND (IV) MINOR DEVICE MODIFICATIONS TO BOTH THE DORNIER LITHOTRIPTER AND THE DORNIER LITHOTRIPTER TRANSPORTABLE
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