|
Device | Nucleus Auditory Brainstem Implant |
Generic Name | Implant, auditory brainstem |
Applicant | Cochlear Americas 10350 Park Meadows Drive Lone Tree, CO 80124 |
PMA Number | P000015 |
Supplement Number | S024 |
Date Received | 07/26/2017 |
Decision Date | 08/23/2017 |
Product Code |
MHE |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Move the manufacturing of the CI500 series Sterile Replacement Magnet and the Non-Magnetic Plug to the Macquarie site where similar manufacturing processes occur. |