Nucleus Auditory Brainstem Implant System
FDA premarket approval P000015/S026 · decided 2018-02-14
Approval details
- PMA number
- P000015
- Supplement
- S026
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Nucleus Auditory Brainstem Implant System
- Generic name
- Implant, auditory brainstem
- Applicant
- Cochlear Americas
- Date received
- 2017-08-25
- Decision date
- 2018-02-14
- Days to decision
- 173 days
- Decision code
- APPR
- Product code
- MHE
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- 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.
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