|Trade Name||INCHECK PATIENT ASSISTANCE, TRANSVENE CS/SVC LEAD|
|Classification Name||implantable cardioverter defibrillator (non-crt)|
|Applicant|| MEDTRONIC INC.|
|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.