PMA P970051S175
- Device
- Necleus 24 Cochlear Implant System
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S175
- Product code
- MCM
- Decision date
- 2018-02-01
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- Removal of the Laminar Flow Units from cleanrooms.
Current openFDA PMA Record#
- Device
- Necleus 24 Cochlear Implant System
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S175
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2018-02-01
- Decision code
- OK30
- Date received
- 2018-01-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Removal of the Laminar Flow Units from cleanrooms.