PMA P000025S135
- Device
- COMBI 40+ COCHLEAR IMPLANT SYSTEM
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S135
- Product code
- MCM
- Decision date
- 2025-04-24
- Classification
- Ear, Nose, Throat
- Generic name
- Implant, cochlear
- Approval order statement
- introduction of an additional laser welding system for the hermetic weld and bakeout of MED-EL Cochlear Implants
Current openFDA PMA Record#
- Device
- COMBI 40+ COCHLEAR IMPLANT SYSTEM
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S135
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2025-04-24
- Decision code
- OK30
- Date received
- 2025-03-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- introduction of an additional laser welding system for the hermetic weld and bakeout of MED-EL Cochlear Implants