MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM WITH C40+, C40+S, OR C40+GB IMPLANTS, AND CIS PRO+/TEMPO+ SPEECH PROCESSORS
FDA premarket approval P000025/S007 · decided 2003-06-05
Approval details
- PMA number
- P000025
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM WITH C40+, C40+S, OR C40+GB IMPLANTS, AND CIS PRO+/TEMPO+ SPEECH PROCESSORS
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2002-12-10
- Decision date
- 2003-06-05
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- APPROVAL OF AN INDICATION FOR USE ALLOWING THE USE OF MAGNETIC RESONANCE IMAGING (MRI) AT 0.2 TESLA FOR PATIENTS IMPLANTED WITH COMBI 40+ COCHLEAR IMPLANTS (C40+, C40+S AND C40+GB ELECTRODE ARRAYS).
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