PMA P970051S095
- Device
- NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S095
- Product code
- MCM
- Decision date
- 2012-09-05
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- RE-COMMISSIONING OF A CLEAN ROOM AND ESTABLISHMENT OF A NEW MANUFACTURING LINE.
Current openFDA PMA Record#
- Device
- NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S095
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2012-09-05
- Decision code
- OK30
- Date received
- 2012-08-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- RE-COMMISSIONING OF A CLEAN ROOM AND ESTABLISHMENT OF A NEW MANUFACTURING LINE.