PMA P970051S153
- Device
- NUCLEUS COCHLEAR IMPLANT SYSTEM
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S153
- Product code
- MCM
- Decision date
- 2016-12-21
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- Manufacturing change to increase the inspection tolerance for the thickness of the silicone over the implant coil.
Current openFDA PMA Record#
- Device
- NUCLEUS COCHLEAR IMPLANT SYSTEM
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S153
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2016-12-21
- Decision code
- OK30
- Date received
- 2016-11-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing change to increase the inspection tolerance for the thickness of the silicone over the implant coil.