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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 TRANSPORTABLE MODULITH SLX LITHOTRIPTER VERSION) ANSPORTABLE VERSION)
Classification Namelithotriptor, extracorporeal shock-wave,urological
Regulation Number876.5990
ApplicantKARL STORZ LITHOTRIPSY-AMERICA, INC.
PMA NumberP920051
Supplement NumberS006
Date Received03/26/1997
Decision Date03/27/1997
Product Code
LNS[ Registered Establishments with LNS ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the oec series 9600 mobile imaging unit and a portable collision protector to be used with a transportable version of your slx lithotripter. The device, as modified, will be marketed under the trade name transportable modulith(r) slx lithotripter and is indicated for use in the noninvasive fragmentation of urinary calculi in the kidney and upper ureter.
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