PMA P130016S060
- Device
- Cochlear Hybrid Implant System
- Applicant
- Cochlear Americas
- PMA number
- P130016
- Supplement
- S060
- Product code
- PGQ
- Decision date
- 2026-04-30
- Classification
- Ear, Nose, Throat
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Approval order statement
- manufacturing process changes at Cochlear's supplier for the CP1110 sound processor rechargeable batteries
Current openFDA PMA Record#
- Device
- Cochlear Hybrid Implant System
- Applicant
- Cochlear Americas
- PMA number
- P130016
- Supplement
- S060
- Product code
- PGQ
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Decision date
- 2026-04-30
- Decision code
- OK30
- Date received
- 2026-03-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- manufacturing process changes at Cochlear's supplier for the CP1110 sound processor rechargeable batteries