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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceSTORZ MODULITH (TM) LITHOTRIPTER
Classification Namelithotriptor, extracorporeal shock-wave,urological
Generic Namelithotriptor, extracorporeal shock-wave,urological
Regulation Number876.5990
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
1201 roberts blvd.
kennesaw, GA 30144
PMA NumberP920051
Date Received11/24/1992
Decision Date02/17/1995
Reclassified Date 09/08/2000
Product Code
LNS[ Registered Establishments with LNS ]
Docket Number 95m-0396
Notice Date 12/15/1995
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
STORZ MODULITH LITHOTRIPTER, MODEL SL20 - THE DEVICE IS AN EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
Supplements: S001 S002 S003 S004 S005 S006 S007 
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