PMA P970051S124
- Device
- COCHLEAR NUCLEUS C1512 IMPLANT SYSTEM
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S124
- Product code
- MCM
- Decision date
- 2014-12-12
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- UPDATE A MISALIGNMENT BETWEEN INSPECTIONS CONDUCTED POST-TOP SHELL FILL MOLDING AND THE SILICONE FINISHING INSPECTION AT SUBSEQUENT OPERATIONS.
Current openFDA PMA Record#
- Device
- COCHLEAR NUCLEUS C1512 IMPLANT SYSTEM
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S124
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2014-12-12
- Decision code
- OK30
- Date received
- 2014-11-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- UPDATE A MISALIGNMENT BETWEEN INSPECTIONS CONDUCTED POST-TOP SHELL FILL MOLDING AND THE SILICONE FINISHING INSPECTION AT SUBSEQUENT OPERATIONS.