PMA P000025S005

Device: MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM, MED-EL INSERTION TEST DEVICE (ITD)
Applicant: Med-El Corp.
PMA number: P000025
Supplement: S005
Product code: MCM
Decision date: 2002-10-29
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order 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.

Current openFDA PMA Record#

Device: MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM, MED-EL INSERTION TEST DEVICE (ITD)
Applicant: Med-El Corp.
PMA number: P000025
Supplement: S005
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2002-10-29
Decision code: APPR
Date received: 2002-10-15
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order 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.