PMA P000025S011

Device: MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
Applicant: Med-El Corp.
PMA number: P000025
Supplement: S011
Product code: MCM
Decision date: 2003-07-22
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR VERTICAL INTEGRATION OF THE COCHLEAR IMPLANT LASER WELDING PROCESS AT THE MANUFACTURING SITE LOCATED AT MED-EL MEDICAL ELECTRONICS, INNSBRUCK, AUSTRIA.

Current openFDA PMA Record#

Device: MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
Applicant: Med-El Corp.
PMA number: P000025
Supplement: S011
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2003-07-22
Decision code: APPR
Date received: 2003-06-18
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR VERTICAL INTEGRATION OF THE COCHLEAR IMPLANT LASER WELDING PROCESS AT THE MANUFACTURING SITE LOCATED AT MED-EL MEDICAL ELECTRONICS, INNSBRUCK, AUSTRIA.