|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||IMPLANTABLE PACEMAKER LEAD|
|Supplement Type||normal 180 day track|
|Supplement Reason|| express gmp supplement|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the manufacturing and labeling facility located at guidant corp. , st. Paul, mn 55112-5798.