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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)
Classification Namelithotriptor, extracorporeal shock-wave,urological
Generic Namelithotriptor, extracorporeal shock-wave,urological
Regulation Number876.5990
Applicant
Dornier MedTech America, Inc.
1155 roberts blvd.
kennesaw, GA 30144
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 change design/components/specifications/material
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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