PMA P970051S134
- Device
- COCHLEAR IMPLANT
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S134
- Product code
- MCM
- Decision date
- 2015-10-14
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- ADDITION OF REWORK AND INSPECTION STEPS TO MANUFACTURING PROCEDURES AT THE MACQUARIE MANUFACTURING FACILITY.
Current openFDA PMA Record#
- Device
- COCHLEAR IMPLANT
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S134
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2015-10-14
- Decision code
- OK30
- Date received
- 2015-09-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF REWORK AND INSPECTION STEPS TO MANUFACTURING PROCEDURES AT THE MACQUARIE MANUFACTURING FACILITY.