|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||PACEMAKER AND CRT-P DEVICES|
|Classification Name||pulse generator, permanent, implantable|
|Generic Name||tiered therapy implantable defibrillator|
|Applicant||ST. JUDE MEDICAL, INC.|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a change to the seal plug for the setscrew (referred to as the septum in the submission).