PMA P000025S007

Device: MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM WITH C40+, C40+S, OR C40+GB IMPLANTS, AND CIS PRO+/TEMPO+ SPEECH PROCESSORS
Applicant: Med-El Corp.
PMA number: P000025
Supplement: S007
Product code: MCM
Decision date: 2003-06-05
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order 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).

Current openFDA PMA Record#

Device: MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM WITH C40+, C40+S, OR C40+GB IMPLANTS, AND CIS PRO+/TEMPO+ SPEECH PROCESSORS
Applicant: Med-El Corp.
PMA number: P000025
Supplement: S007
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2003-06-05
Decision code: APPR
Date received: 2002-12-10
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order 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).