|Trade Name||NUCLEUS 24 COCHLEAR IMPLANT SYSTEM|
|Classification Name||implant, cochlear|
||Ear Nose & Throat
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a change in the allowable tolerances of the silicone overmold in the distal portion of the receiving coil for the ci500 series cochlear implants.