NUCLEUS AUDITORY BRAINSTEM IMPLANT
FDA premarket approval P000015/S018 · decided 2016-12-21
Approval details
- PMA number
- P000015
- Supplement
- S018
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NUCLEUS AUDITORY BRAINSTEM IMPLANT
- Generic name
- Implant, auditory brainstem
- Applicant
- Cochlear Americas
- Date received
- 2016-11-23
- Decision date
- 2016-12-21
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MHE
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Introduce a semi-automatic process that uses silicone molding tools as an alternate to the manual silicone molding process currently used in the top shell underfill process for the implant.
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