|Trade Name||STORZ MODULITH (TM) LITHOTRIPTER|
|Applicant||KARL STORZ ENDOSCOPY-AMERICA, INC.|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| 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).