|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||CAPSUREFIX MRI LEAD|
|Classification Name||implantable pulse generator, pacemaker (non-crt)|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Alternate supplier of a silicone component and for inspections of that component to be performed by the supplier for lot release.