|Trade Name||INSYNC III CRT-P & INSYNC CRT-P|
|Classification Name||implantable pulse generator, pacemaker (non-crt)|
|Applicant|| MEDTRONIC INC.|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Reduction in the sampling frequency of routine environmental monitoring in the controlled environment are at medtronic puerto rico operations company in juncos, puerto rico.