|Trade Name||EPICARDIAL PATCH LEADS|
|Classification Name||implantable cardioverter defibrillator (non-crt)|
|Applicant|| MEDTRONIC INC.|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval change in silicone tubing material used in the manufacturing of various cardiac leads as a result of discontinuation of the current material by an outside supplier.