PMA P000025S065

Device: COMBI 40+ COCHLEAR IMPLANT SYSTEM (MAESTRO COCHLEAR SYSTEM)
Applicant: Med-El Corp.
PMA number: P000025
Supplement: S065
Product code: MCM
Decision date: 2012-10-15
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: ADDITION OF A NEW LASER WELDING SYSTEM FOR THE PURPOSES OF WELDING IMPLANT HOUSINGS TO IMPLANT HEADERS FOR THE MI1000 MED-EL CONCERT MODEL COCHLEAR IMPLANTS.

Current openFDA PMA Record#

Device: COMBI 40+ COCHLEAR IMPLANT SYSTEM (MAESTRO COCHLEAR SYSTEM)
Applicant: Med-El Corp.
PMA number: P000025
Supplement: S065
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2012-10-15
Decision code: OK30
Date received: 2012-09-17
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ADDITION OF A NEW LASER WELDING SYSTEM FOR THE PURPOSES OF WELDING IMPLANT HOUSINGS TO IMPLANT HEADERS FOR THE MI1000 MED-EL CONCERT MODEL COCHLEAR IMPLANTS.