|Trade Name||ATTAIN OTW|
|Classification Name||implantable pulse generator, pacemaker (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 for a new kit containing individually packaged lead anchoring sleeves. The kit will be marketed under the trade name model 5867 as anchoring sleeve kit and is intended for use with the medtronic implantable endocardial lead families listed.