PMA P000025S088
- Device
- COMBI 40+ COCHLEAR IMPLANT SYSTEM
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S088
- Product code
- MCM
- Decision date
- 2016-07-08
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- Gain additional manufacturing space and flexibility with respect to allocation of work spaces for implant production and process flow within implant manufacturing.
Current openFDA PMA Record#
- Device
- COMBI 40+ COCHLEAR IMPLANT SYSTEM
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S088
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2016-07-08
- Decision code
- OK30
- Date received
- 2016-06-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Gain additional manufacturing space and flexibility with respect to allocation of work spaces for implant production and process flow within implant manufacturing.