PMA P970051S116
- Device
- NUCLEUS CI512 COCHLEAR IMPLANT
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S116
- Product code
- MCM
- Decision date
- 2015-01-22
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- Approval for a manufacturing site located at Cochlear Limited - Macquarie, 1 University Avenue, Macquarie University, NSW 2109, Australia.
Current openFDA PMA Record#
- Device
- NUCLEUS CI512 COCHLEAR IMPLANT
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S116
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2015-01-22
- Decision code
- APPR
- Date received
- 2014-01-27
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a manufacturing site located at Cochlear Limited - Macquarie, 1 University Avenue, Macquarie University, NSW 2109, Australia.