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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 NameSTORZ MODULITH LITHOTRIPTER, MODEL SLX FOR FRAGMENTATION OF URINARY AND UPPER URETERAL CALCULI (MOBILE VERSION)
Classification Namelithotriptor, extracorporeal shock-wave,urological
Regulation Number876.5990
ApplicantKARL STORZ LITHOTRIPSY-AMERICA, INC.
PMA NumberP920051
Supplement NumberS004
Date Received08/30/1996
Decision Date01/10/1997
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 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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