PMA P970051S094
- Device
- NUCLEUS COCHLEAR IMPLANT SYSTEMS
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S094
- Product code
- MCM
- Decision date
- 2014-01-21
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- APPROVAL FOR THE COCHLEAR INTEGRITY TEST SYSTEM (CITS).
Current openFDA PMA Record#
- Device
- NUCLEUS COCHLEAR IMPLANT SYSTEMS
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S094
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2014-01-21
- Decision code
- APPR
- Date received
- 2012-08-02
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE COCHLEAR INTEGRITY TEST SYSTEM (CITS).