|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 Name||THE SPANNER TEMPORARY PROSTATIC STENT|
|Classification Name||stent, urethral, prostatic, semi-permanent|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a design change to add an access tether, called the shore line to the device.