|Trade Name||CONTAK CD/EASYTRAK|
|Classification Name||implantable pulse generator, pacemaker (non-crt)|
|Generic Name||pulse generator|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the addition of in-line lal testing (pyrogenicity testing) to the inspection procedure for each incoming lot received at guidant for the universal finishing wire accessories.