PMA P970051S093
- Device
- NUCLEUS COCHLEAR IMPLANT SYSTEM
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S093
- Product code
- MCM
- Decision date
- 2013-01-03
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- APPROVAL FOR A NEW VERSION OF THE CUSTOM SOUND SOFTWARE FOR PROGRAMMING OF THE NUCLEUS COCHLEAR IMPLANTS, TO BE KNOWN AS CUSTOM SOUND 3.3.
Current openFDA PMA Record#
- Device
- NUCLEUS COCHLEAR IMPLANT SYSTEM
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S093
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2013-01-03
- Decision code
- APPR
- Date received
- 2012-07-31
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A NEW VERSION OF THE CUSTOM SOUND SOFTWARE FOR PROGRAMMING OF THE NUCLEUS COCHLEAR IMPLANTS, TO BE KNOWN AS CUSTOM SOUND 3.3.