PMA P970051S105
- Device
- NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S105
- Product code
- MCM
- Decision date
- 2013-10-23
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- ADDITIONAL SUPPLIER OF A COMPONENT AND ADDITIONAL SPECIFICATIONS ON CLEANING, PACKAGING AND INSPECTION OF THESE COMPONENTS.
Current openFDA PMA Record#
- Device
- NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S105
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2013-10-23
- Decision code
- APPR
- Date received
- 2013-02-07
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITIONAL SUPPLIER OF A COMPONENT AND ADDITIONAL SPECIFICATIONS ON CLEANING, PACKAGING AND INSPECTION OF THESE COMPONENTS.