PMA P990052S012

Device: VIBRANT SOUNDBRIDGE MIDDLE EAR IMPLANT SYSTEM
Applicant: Med-El Elektromedizinische Gerate GmbH
PMA number: P990052
Supplement: S012
Product code: MPV
Decision date: 2006-10-13
Classification: Implant, Hearing, Active, Middle Ear, Partially Implanted
Generic name: Implant, hearing, active, middle ear, partially implanted
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT MED-EL ELEKTROMEDIZINISCHE GERATE (CONTRACT MANUFACTURER FOR VIBRANT MED-EL) GMBH OF INNSBRUCK, AUSTRIA, FOR THE LASER WELDING OF THE PRE WELDED DEMODULATOR UNIT AND THE BOBBIN.

Current openFDA PMA Record#

Device: VIBRANT SOUNDBRIDGE MIDDLE EAR IMPLANT SYSTEM
Applicant: Med-El Elektromedizinische Gerate GmbH
PMA number: P990052
Supplement: S012
Product code: MPV
Generic name: Implant, hearing, active, middle ear, partially implanted
Decision date: 2006-10-13
Decision code: APPR
Date received: 2005-12-01
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT MED-EL ELEKTROMEDIZINISCHE GERATE (CONTRACT MANUFACTURER FOR VIBRANT MED-EL) GMBH OF INNSBRUCK, AUSTRIA, FOR THE LASER WELDING OF THE PRE WELDED DEMODULATOR UNIT AND THE BOBBIN.