PMA P130016S019
- Device
- NUCLEUS HYBRID L24 IMPLANT SYSTEM
- Applicant
- Cochlear Americas
- PMA number
- P130016
- Supplement
- S019
- Product code
- PGQ
- Decision date
- 2016-10-28
- Classification
- Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Approval order statement
- Approval to outsource the piercing of the hermetization hole in the top shell to an approved supplier for the CI24RE(ST), CI24RE(CA), CI422 and Hybrid L24 implants.
Current openFDA PMA Record#
- Device
- NUCLEUS HYBRID L24 IMPLANT SYSTEM
- Applicant
- Cochlear Americas
- PMA number
- P130016
- Supplement
- S019
- Product code
- PGQ
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Decision date
- 2016-10-28
- Decision code
- APPR
- Date received
- 2016-06-15
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to outsource the piercing of the hermetization hole in the top shell to an approved supplier for the CI24RE(ST), CI24RE(CA), CI422 and Hybrid L24 implants.