MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA premarket approval P000025/S054 · decided 2012-04-20
Approval details
- PMA number
- P000025
- Supplement
- S054
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2011-06-20
- Decision date
- 2012-04-20
- Days to decision
- 305 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- APPROVAL FOR A CHANGE TO THE PACKAGING CONFIGURATION OF YOUR SONATATI100 COCHLEAR IMPLANT AND THE IMPLANT TEMPLATE, SINGLE USE, FOR THE SONATATI100. THIS CHANGE WILL ENABLE THE SONATA SINGLE USE TEMPLATE TO BE SHIPPED TOGETHER WITH THE SONATATI100 COCHLEAR IMPLANT INSIDE THE IMPLANT BOX.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.