|Trade Name||CONTAK RENEWAL TR MODELS H120 AND H125|
|Classification Name||pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)|
|Generic Name||cardiac resynchronization therapy pacemaker (crt-p)|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Changes made to the software of the automated setscrew preload system for the models listed that were inadvertently left ou of a previous 30-day notice.