Nucleus Auditory Brainstem Implant System
FDA premarket approval P000015/S030 · decided 2018-03-02
Approval details
- PMA number
- P000015
- Supplement
- S030
- Supplement type
- 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
- 2018-02-02
- Decision date
- 2018-03-02
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MHE
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Relocation of four subassembly manufacturing processes from the Macquarie facility to the Lane Cove facility.
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