|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||system, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy|
|Generic Name||system, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Upgrades in 1)the luxtron thermometry unit from model 3000-4 to model 3100; 2) the computer processor from 386 to pentium; and 3) the software from version 3. 07 to version 3. 09.