|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 AND ACCESSORIES|
|Classification Name||stent, urethral, prostatic, semi-permanent|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Utilization of a larger existing cleanroom within the current manufacturing facility.