PMA P130016S013
- Device
- NUCLEUS 24 HYBRID SYSTEM
- Applicant
- Cochlear Americas
- PMA number
- P130016
- Supplement
- S013
- Product code
- PGQ
- Decision date
- 2015-12-30
- 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 FOR A CHANGE TO THE PRE-STERILIZATION CLEANING PROCESS TO ALLOW FOR ADDITIONAL DEVICES TO BE CLEANED PRIOR TO THE STERILIZATION CYCLE.
Current openFDA PMA Record#
- Device
- NUCLEUS 24 HYBRID SYSTEM
- Applicant
- Cochlear Americas
- PMA number
- P130016
- Supplement
- S013
- Product code
- PGQ
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Decision date
- 2015-12-30
- Decision code
- OK30
- Date received
- 2015-12-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A CHANGE TO THE PRE-STERILIZATION CLEANING PROCESS TO ALLOW FOR ADDITIONAL DEVICES TO BE CLEANED PRIOR TO THE STERILIZATION CYCLE.