MED-EL COMBI 40+

FDA premarket approval P000025/S010 · decided 2003-07-25

Approval details

PMA number

P000025

Supplement

S010

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

MED-EL COMBI 40+

Generic name

Implant, cochlear

Applicant

Med-El Corp.

Date received

2003-06-16

Decision date

2003-07-25

Days to decision

39 days

Decision code

APPR

Product code

MCM

Advisory committee

Ear, Nose, Throat

Expedited review

No

Location

Innsbruck

Statement

APPROVAL FOR THE MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM TO INCLUDE THE FOLLOWING ACCESSORIES FOR THE TEMPO+ SPEECH PROCESSOR: TELEMIC AND MICROPHONE TEST DEVICE (MTD). THE TELEMIC IS INDICATED FOR THE COMBI 40+ COCHLEAR IMPLANT USER WHO DESIRES EITHER A DIRECT CONNECTION TO A TELEPHONE OR AN INDUCTION LOOP OR ADDITIONAL AMPLIFICATION OF THE TEMPO+ SPEECH PROCESSOR INTERNAL MICROPHONE. THE MTD IS INDICATED FOR INDIVIDUALS WHO WISH TO QUALITATIVELY MONITOR THE MICROPHONE SIGNAL OF THE TEMPO+ SPE