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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 (TM) LITHOTRIPTER
ApplicantKARL STORZ LITHOTRIPSY-AMERICA, INC.
PMA NumberP920051
Supplement NumberS002
Date Received09/18/1995
Decision Date12/11/1995
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 for the following device modifications: 1)inclusion of an upgraded video mixer; 2) modification of the water circuit to include pressure feedback; 3) replacement of the nylon/aluminum patient table with a carbon fiber model; 4) addition of the fvp-30 x-ray image processing feature (which also included revisions ot the x-ray operator's and service manuals).
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