PMA P000025S133
- Device
- MED-EL Cochlear Implant System
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S133
- Product code
- MCM
- Decision date
- 2024-09-13
- Classification
- Ear, Nose, Throat
- Generic name
- Implant, cochlear
- Approval order statement
- approval for applying automatic evaluation of the in-house sterilization system (IHS) parameters
Current openFDA PMA Record#
- Device
- MED-EL Cochlear Implant System
- Applicant
- Med-El Corp.
- PMA number
- P000025
- Supplement
- S133
- Product code
- MCM
- Generic name
- Implant, cochlear
- Decision date
- 2024-09-13
- Decision code
- OK30
- Date received
- 2024-08-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for applying automatic evaluation of the in-house sterilization system (IHS) parameters