|Trade Name||ATTAIN ABILITY|
|Classification Name||drug eluting permanent left ventricular (lv) pacemaker electrode|
|Applicant|| MEDTRONIC INC.|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Update the drug component and finished lead specification of the attain ability family of leads and the addition of an alternate testing laboratory an alternate analytical methods.