Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: Nucleus Auditory Brainstem Implant System
• Generic Name: Implant, auditory brainstem
• Applicant: Cochlear Americas; 10350 Park Meadows Dr.; Lone Tree, CO 80124
• PMA Number: P000015
• Supplement Number: S033
• Date Received: 08/13/2018
• Decision Date: 09/10/2018
• 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
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
New internal electrode supplier for the rechargeable battery assemblies.