|Classification Name||implantable cardioverter defibrillator (non-crt)|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for lead stabilizer kit 6503 and lead cap kit 6504, which are accessory kits intended to be used with the boston scientific corporation (bsc) lead products approved in the devices.