|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, END CAP, SIZING SLEEVE, , UPSIZING SLEEVE|
|Classification Name||implantable cardioverter defibrillator (non-crt)|
|Supplement Type||real-time process|
|Supplement Reason|| process change: packaging|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for an increase in the storage shelf life of the tyvek lid component, which includes the adhesive coating, used in the medtronic cardiac rhythm disease management products from 18 months to 48 months.