|Trade Name||STORZ TRANSPORTABLE MODULITH SLX LITHOTRIPTER VERSION) ANSPORTABLE VERSION)|
|Classification Name||lithotriptor, extracorporeal shock-wave,urological|
|Applicant||KARL STORZ LITHOTRIPSY-AMERICA, INC.|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - other|
|Expedited Review Granted?|| 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.