MED-EL EAS EXTENDED COCHLEAR IMPLANT SYSTEM
FDA premarket approval P000025/S092 · decided 2016-12-08
Approval details
- PMA number
- P000025
- Supplement
- S092
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- MED-EL EAS EXTENDED COCHLEAR IMPLANT SYSTEM
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Applicant
- Med-El Corp.
- Date received
- 2016-10-13
- Decision date
- 2016-12-08
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- PGQ
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- Approval of the protocol for the post-approval study.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.