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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 DELTA LITHOTRIPTER-STATIONARY, MOBILE AND TRANSPORTABLE/FS2000 X-RAY MODULE
Classification Namelithotriptor, extracorporeal shock-wave,urological
Generic Nameextracorporeal shock-wave lithotripter
Regulation Number876.5990
ApplicantDORNIER MEDTECH AMERICA, INC.
PMA NumberP840008
Supplement NumberS069
Date Received08/20/1999
Decision Date09/02/1999
Product Code
LNS[ Registered Establishments with LNS ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change that would allow the option of a rotating x-ray anode in addition to the currently available stationary anode.
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