|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||NUCLEUS COCHLEAR IMPLANT SYSTEM|
|Classification Name||implant, cochlear|
||Ear Nose & Throat
|Supplement Type||135 review track for 30-day notice|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a change to move the inner and outer moulding process of a transformer pod in-house, and modify the shape of the inner-mould.