PMA P970051S186
- Device
- Nucleus 24 Cochlear Implant Sysstem
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S186
- Product code
- MCM
- Decision date
- 2019-07-02
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- Addition of an x-ray screening step post shot 1 silicone molding.
Current openFDA PMA Record#
- Device
- Nucleus 24 Cochlear Implant Sysstem
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S186
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2019-07-02
- Decision code
- OK30
- Date received
- 2019-06-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an x-ray screening step post shot 1 silicone molding.