|
Device | Nucleus Auditory Brainstem Implant System |
Generic Name | Implant, auditory brainstem |
Applicant | Cochlear Americas 10350 Park Meadows Drive Lone Tree, CO 80124 |
PMA Number | P000015 |
Supplement Number | S026 |
Date Received | 08/25/2017 |
Decision Date | 02/14/2018 |
Product Code |
MHE |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the use of coupons for residual gas analysis (RGA) testing for hermeticity and to remove the requirement of batch release based on RGA testing. |