|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||LEAD ADAPTERS, MODEL NUMBERS 6833, 6836, AND 6931|
|Classification Name||implantable cardioverter defibrillator (non-crt)|
|Generic Name||transvenous defibrillation lead; accessory stylets|
|Supplement Type||30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change in the supplier for the mold release, a change in the type of lubricant, and a change in the process of applying the lubricant.