|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||ACE HEADER, APPLICATION SOFTWARE, DEFRILLATION SUPPORT DEVICE (DISD) END CAP, EPICCARDIAL PATCH LEAD SIZILING SLEEVE UPS|
|Classification Name||implantable cardioverter defibrillator (non-crt)|
|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.