PMA P970051S231
- Device
- Nucleus CI632 Cochlear Implant, Nucleus CI532 Cochlear Implant
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S231
- Product code
- MCM
- Decision date
- 2024-11-15
- Classification
- Ear, Nose, Throat
- Generic name
- Implant, cochlear
- Approval order statement
- introduction of EA32 production lines in the new cleanroom 5 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
- S231
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2024-11-15
- Decision code
- OK30
- Date received
- 2024-10-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- introduction of EA32 production lines in the new cleanroom 5 at the Lane Cove Manufacturing Site