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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.
Classification Namelithotriptor, extracorporeal shock-wave,urological
Generic Namelithotriptor, extracorporeal shock-wave,urological
Regulation Number876.5990
Dornier MedTech America, Inc.
1155 roberts blvd.
kennesaw, GA 30144
PMA NumberP840008
Supplement NumberS065
Date Received06/25/1998
Decision Date07/07/1998
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 tot he therapy head movement capabilities, alteration of the hand held control unit, modification of the X-ray range of movement, addition of an X-ray image storage feature, ECG monitor model replacement, replacement of the charging unit, a new mounting orientation for the ultrasound arm, design changes to the patient table, a new design for the phantom support accessory, software modifications, and labeling changes. The device, as modified, will be marketed under the trade name Dornier Compact Delta Lithotripter and is indicated for fragmentation of 5 to 25 millimeter kidney stones such as renal calyx stones and renal pelivc stones.