|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|
|Supplement Type||normal 180 day track|
|Supplement Reason|| postapproval protocol or modification to a protocol|
|Expedited Review Granted?|| No|
|Approval Order Statement |
1)contained the final report of postapproval study regarding the possible relationship between extracorporeal shock wave lithotripsy and the onset of hypertension, and 2) requested approval for modifications to the tripter-x1's labeling to reflect the results of this final report.