PMA P970051S232
- Device
- Nucleus CI632 Cochlear Implant, Nucleus CI532 Cochlear Implant
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S232
- Product code
- MCM
- Decision date
- 2024-11-13
- Classification
- Ear, Nose, Throat
- Generic name
- Implant, cochlear
- Approval order statement
- for addition of a new cleanroom at the Lane Cove manufacturing site
Current openFDA PMA Record#
- Device
- Nucleus CI632 Cochlear Implant, Nucleus CI532 Cochlear Implant
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S232
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2024-11-13
- Decision code
- OK30
- Date received
- 2024-10-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- for addition of a new cleanroom at the Lane Cove manufacturing site