MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM, MED-EL INSERTION TEST DEVICE (ITD)
FDA premarket approval P000025/S005 · decided 2002-10-29
Approval details
- PMA number
- P000025
- Supplement
- S005
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM, MED-EL INSERTION TEST DEVICE (ITD)
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2002-10-15
- Decision date
- 2002-10-29
- Days to decision
- 14 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- APPROVAL FOR THE MED-EL SURGICAL CLAW, WORKING ANGLE -45 DEGREES, AS A MODIFICATION OF THE MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MED-EL SURGICAL CLAW, WORKING ANGLE -45 DEGREES, AND IS INDICATED FOR USE WHERE THERE IS PLANNED ACCESS TO THE INNER EAR DURING SURGERY.
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