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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 COMPACT S MOBILE
Classification Namelithotriptor, extracorporeal shock-wave,urological
Generic Nameextracorporeal shock-wave lithotripter
Regulation Number876.5990
ApplicantDORNIER MEDTECH AMERICA, INC.
PMA NumberP840008
Supplement NumberS059
Date Received12/16/1996
Decision Date12/20/1996
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 of a mobile version of the compact s lithotripter. The device, as modified, will be marketed under the trade name dornier compact s mobile and is indicated for the fragmentation of 5 to 25 millimeter kidney stones such as renal calyx stones and renal pelvice stones.
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