PMA P970051S070
- Device
- NUCLEUS COCHLEAR IMPLANT SYSTEM
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S070
- Product code
- MCM
- Decision date
- 2011-08-30
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- APPROVAL FOR A CHANGE TO THE DIAMETER SPECIFICATION OF THE WIRE USED IN THE ELECTRODES OF THE COCHLEAR IMPLANT SYSTEM.
Current openFDA PMA Record#
- Device
- NUCLEUS COCHLEAR IMPLANT SYSTEM
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S070
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2011-08-30
- Decision code
- APPR
- Date received
- 2011-05-16
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A CHANGE TO THE DIAMETER SPECIFICATION OF THE WIRE USED IN THE ELECTRODES OF THE COCHLEAR IMPLANT SYSTEM.