PMA P970051S107
- Device
- NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S107
- Product code
- MCM
- Decision date
- 2013-11-13
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- APPROVAL FOR INTRODUCTION OF A CONTAINED HELIUM LEAK TEST.
Current openFDA PMA Record#
- Device
- NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
- Applicant
- Cochlear Americas
- PMA number
- P970051
- Supplement
- S107
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2013-11-13
- Decision code
- APPR
- Date received
- 2013-03-27
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR INTRODUCTION OF A CONTAINED HELIUM LEAK TEST.