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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 NumberS064
Date Received05/26/1998
Decision Date06/05/1998
Product Code
LNS[ Registered Establishments with LNS ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the therapy head positioning, modifications of the control panel, addition of a servicing modem, changes to the air flow within the device, material changes to the patient table, ecg monitor model replacement, change of the available x-ray features, software modifications, labeling changes, and integration of the water circulation device with its control computer. The device, as modified, will be marketed under the trade name dorneir lithotripter s and is indicated for the fragmentation of 5 to 25 millimeter kidney stones such as renal calyx stones and renal pelvic stones.
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