MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA premarket approval P000025/S004 · decided 2002-09-04
Approval details
- PMA number
- P000025
- Supplement
- S004
- 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
- 2002-08-20
- Decision date
- 2002-09-04
- Days to decision
- 15 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- APPROVAL FOR THE MODIFICATION TO REPLACE COMBI 40+ COCHLEAR IMPLANT SYSTEM "INSERTION ELECTRODE" WITH THE INSERTION TEST DEVICE (ITD). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MED-EL INSERTION TEST DEVICE AND IS INDICATED FOR INDIVIDUALS UNDERGOING COCHLEAR IMPLANT SURGERIES AFTER A MASTOIDECTOMY, POSTERIOR TYMPANOTOMY, AND COCHLEOSTOMY HAVE BEEN PERFORMED AND WHERE ACCESS TO THE COCHLEA HAS BEEN SECURED.
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