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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 COMPACT S MOBILE
Generic NameLithotriptor, extracorporeal shock-wave, urological
Regulation Number876.5990
ApplicantDornier Medtech America, Inc.
1155 Roberts Blvd.
Kennesaw, GA 30144
PMA NumberP840008
Supplement NumberS059
Date Received12/16/1996
Decision Date12/20/1996
Reclassified Date09/08/2000
Product Code LNS 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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