|Trade Name||SELECTSECURE LEAD|
|Classification Name||permanent defibrillator electrodes|
|Applicant|| MEDTRONIC INC.|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the following changes: 1) a change in the manufacturing facility for the drug vial filling process; 2) the addition of a contract laboratory for drug release testing; and 3) a change in a quality control test used to determine a specific attribute of an incoming raw material.