|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||ATTAIN BIPOLAR OTW LEAD, CONSULTA CRT-P,SYNCRA CRT-P|
|Classification Name||pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Relocation for the performance of selected inspection activities used for incoming/receiving for selected medtronic cardiac rhythm disease management (crdm) products.