Nucleus 24 Cochlear Implant System
FDA premarket approval P970051/S165 · decided 2017-07-06
Approval details
- PMA number
- P970051
- Supplement
- S165
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Nucleus 24 Cochlear Implant System
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2017-06-07
- Decision date
- 2017-07-06
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- External supplier, Jabil Circuit in China, to be added as an alternate supplier of the CP800 Series Tamper resistant Battery Cover, CP800 Series Battery Holder and Nucleus Battery Holder components. A change was also requested to the solder material used in the battery holder printed circuit board assembly (PCBA).
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.