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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 (STATIONARY AND MOBILE)
Generic NameLithotriptor, extracorporeal shock-wave, urological
Regulation Number876.5990
ApplicantDornier MedTech America, Inc.
1155 ROBERTS BLVD.
KENNESAW, GA 30144
PMA NumberP840008
Supplement NumberS061
Date Received10/21/1997
Decision Date11/03/1997
Reclassified Date 09/08/2000
Product Code LNS 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval to offer the Dornier X-ray Imaging Module, the Extended Image Stoarage component, and an alterantive electrocardiogram monitor as options ofor your device. In addition, the Advance Technology Laboratories ultrasound system will no longer be an option on your device. Finall, the wording of your precaution on hypertension has been modified as requested by FDA after our review of your postapproval study results.
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