|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.|
|Classification Name||lithotriptor, extracorporeal shock-wave,urological|
|Generic Name||lithotriptor, extracorporeal shock-wave,urological|
|Supplement Type||normal 180 day track|
|Supplement Reason|| labeling change - indications/instructions/shelf life/tradename|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for modifying your user's manual. The device, as modified, will be marketed under the trade name lithostar.