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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
Classification Namelithotriptor, extracorporeal shock-wave,urological
Generic Namelithotriptor, extracorporeal shock-wave,urological
Regulation Number876.5990
Applicant
Dornier MedTech America, Inc.
1155 roberts blvd.
kennesaw, GA 30144
PMA NumberP840008
Supplement NumberS056
Date Received07/01/1996
Decision Date11/05/1996
Product Code
LNS[ Registered Establishments with LNS ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
DESIGN MODIFICATIONS:1)THE USE OF THE PERFORMA ULTRASOUND IMAGING SYSTEM 2)ADDITION OF X-RAY IMAGING AND 3)MINOR DESIGN CHANGES. THE DEVICE AS MODIFIED WILL E MARKETD UNDER THE TRADE NAME DORNIER COMPACT S LITHOTRIPTER AND IS INDICATED FOR THE FRAGMENTATION OF 5 TO 25 MILLIMETER KIDNEY STONES SUCH AS RENAL CALYX STONES AND RENAL PELVIC STONES
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