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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 NameDORNIER LITHOTRIPTER (STATIONARY AND MOBILE)
Classification Namelithotriptor, extracorporeal shock-wave,urological
Generic Nameextracorporeal shock-wave lithotripter
Regulation Number876.5990
ApplicantDORNIER MEDTECH AMERICA, INC.
PMA NumberP840008
Supplement NumberS061
Date Received10/21/1997
Decision Date11/03/1997
Product Code
LNS[ Registered Establishments with LNS ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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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