MED-EL Cochlear Implant System
FDA premarket approval P000025/S101 · decided 2018-07-25
Approval details
- PMA number
- P000025
- Supplement
- S101
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MED-EL Cochlear Implant System
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2018-06-25
- Decision date
- 2018-07-25
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- Removal of the AETA (Automated Electrode Test Application) as a mandatory test to be performed on all standard Cl electrodes.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.