|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||CAPSURE SENSE LEAD,CAPSURE SP NOVUS LEAD,VITATRON CRYSTALLINE LEAD,VITATRON EXCELLENCE PS+ LEAD|
|Classification Name||permanent defibrillator electrodes|
|Generic Name||electrode, pacemaker, permanent|
|Supplement Type||30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Update to the manufacturing and inspection process for tubing used in medtronic crdm therapy delivery products.