|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||AID-B/BR AND VENTAK ICD|
|Classification Name||implantable cardioverter defibrillator (non-crt)|
|Supplement Type||real-time process|
|Supplement Reason|| labeling change - instructions|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to add the use of mineral oil to device labeling.