|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||ILESTO 7 HF-T, ILESTO 5 HF-T, IFORIA 7 HF-T IFORIA 5 HF-T, INVENTRA 7 HF-T (DF-1), INVENTRA 7 HF-T (DF4), IPERIA 7HF-T (|
|Classification Name||defibrillator, implantable, dual-chamber|
|Supplement Type||30-day notice|
|Supplement Reason|| process change - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change to the spring bushings used in the device header and the associated manufacturing equipment.