Nucleus Auditory Brainstem Implant
FDA premarket approval P000015/S024 · decided 2017-08-23
Approval details
- PMA number
- P000015
- Supplement
- S024
- 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
- 2017-07-26
- Decision date
- 2017-08-23
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MHE
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Move the manufacturing of the CI500 series Sterile Replacement Magnet and the Non-Magnetic Plug to the Macquarie site where similar manufacturing processes occur.
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