|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||IGOTIS 5 HF-T (DF-4), 7 HF-T (DF-4, LI); IFORIA 7 HF-T (DF4, GB) IIESTO 5 HF-TIESTO 5 HF-T (DF-4)|
|Classification Name||defibrillator, implantable, dual-chamber|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Changes to equipment used in the production of is-1 connector ports.