PMA P970051S138
- Device
- NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S138
- Product code
- MCM
- Decision date
- 2015-12-30
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- 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 COCHLEAR IMPLANT SYSTEM
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S138
- Product code
- MCM
- Generic name
- Implant, cochlear
- 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