Cochlear Hybrid Implant System
FDA premarket approval P130016/S060 · decided 2026-04-30
Approval details
- PMA number
- P130016
- Supplement
- S060
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Cochlear Hybrid Implant System
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Applicant
- Cochlear Americas
- Date received
- 2026-03-31
- Decision date
- 2026-04-30
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- PGQ
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- manufacturing process changes at Cochlear's supplier for the CP1110 sound processor rechargeable batteries
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