PMA P000025S095
- Device
- Combi 40+ Cochlear Implant System
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S095
- Product code
- MCM
- Decision date
- 2017-06-01
- Classification
- Implant, Cochlear
- Generic name
- Implant, cochlear
- Approval order statement
- Addition of a second laser welding process in the manufacture of SONATA cochlear implants.
Current openFDA PMA Record#
- Device
- Combi 40+ Cochlear Implant System
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S095
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2017-06-01
- Decision code
- OK30
- Date received
- 2017-05-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a second laser welding process in the manufacture of SONATA cochlear implants.