PMA P000015S003
- Device
- NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM
- Applicant
- Cochlear Americas
- PMA number
- P000015
- Supplement
- S003
- Product code
- MCM
- Decision date
- 2002-12-09
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- APPROVAL FOR EXPANSION OF THE MANUFACTURING FACILITY LOCATED AT COCHLEAR LIMITED, LANE COVE, AUSTRALIA.
Current openFDA PMA Record#
- Device
- NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM
- Applicant
- Cochlear Americas
- PMA number
- P000015
- Supplement
- S003
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2002-12-09
- Decision code
- APPR
- Date received
- 2002-10-31
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR EXPANSION OF THE MANUFACTURING FACILITY LOCATED AT COCHLEAR LIMITED, LANE COVE, AUSTRALIA.