MED-EL Cochlear Implant System
FDA premarket approval P000025/S130 · decided 2023-12-22
Approval details
- PMA number
- P000025
- Supplement
- S130
- 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
- 2023-11-24
- Decision date
- 2023-12-22
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- expansion and creation of new environmentally controlled areas used for production of cochlear implant components and single use surgical tools, and for packaging of these products prior to sterilization
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.