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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.
 
DeviceSTORZ MODULITH LITHOTRIPTER, MODEL SLX FOR FRAGMENTATION OF URINARY AND UPPER URETERAL CALCULI (MOBILE VERSION)
Generic NameLithotriptor, extracorporeal shock-wave, urological
Regulation Number876.5990
ApplicantKARL STORZ ENDOSCOPY-AMERICA, INC.
1201 ROBERTS BLVD.
KENNESAW, GA 30144
PMA NumberP920051
Supplement NumberS004
Date Received08/30/1996
Decision Date01/10/1997
Reclassified Date 09/08/2000
Product Code LNS 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL OF A MOBILE VERSION OF THE MODULITH(R) SLX LITHOTRIPTER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME THE STORZ MODULITH(R) SLX MOBILE LITHOTRIPTER, AND IS INDICATED FOR USE IN THE NONINVASIVE GRAGMENTATION OF URINARY CALCULI IN THE KIDNEY AND UPPER URETER.
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