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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 AND DORNIER LITHOTRIPTER TRANSPORTABLE
Classification Namelithotriptor, extracorporeal shock-wave,urological
Generic Nameextracorporeal shock-wave lithotriptor
Regulation Number876.5990
ApplicantDORNIER MEDTECH AMERICA, INC.
PMA NumberP840008
Supplement NumberS054
Date Received03/22/1996
Decision Date10/08/1996
Product Code
LNS[ Registered Establishments with LNS ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for (i) a patient automatic positioning feature, (ii) patient data managment software, (iii) the performa ultrasound syste, and (iv) minor device modifications to both the dornier lithotripter and the dornier lithotripter transportable.
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