PMA P970051S106
- Device
- NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S106
- Product code
- MCM
- Decision date
- 2013-03-22
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- INTRODUCTION OF ALTERNATIVE NEW CUTTING LATHES AND CHANGES TO CUTTING PROCESS MONITORING METHOD.
Current openFDA PMA Record#
- Device
- NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S106
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2013-03-22
- Decision code
- OK30
- Date received
- 2013-02-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- INTRODUCTION OF ALTERNATIVE NEW CUTTING LATHES AND CHANGES TO CUTTING PROCESS MONITORING METHOD.