PMA P990052S013

Device: VIBRANT SOUNDBRIDGE
Applicant: Med-El Elektromedizinische Gerate GmbH
PMA number: P990052
Supplement: S013
Product code: MPV
Decision date: 2006-11-02
Classification: Implant, Hearing, Active, Middle Ear, Partially Implanted
Generic name: Implant, hearing, active, middle ear, partially implanted
Approval order statement: APPROVAL TO ESTABLISH A SECOND SOURCE SUPPLIER, MORGAN ADVANCED CERAMICS, FOR THE DEMODULATOR HOUSING (IMPLANT ELECTRONICS CASE).

Current openFDA PMA Record#

Device: VIBRANT SOUNDBRIDGE
Applicant: Med-El Elektromedizinische Gerate GmbH
PMA number: P990052
Supplement: S013
Product code: MPV
Generic name: Implant, hearing, active, middle ear, partially implanted
Decision date: 2006-11-02
Decision code: APPR
Date received: 2006-07-12
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL TO ESTABLISH A SECOND SOURCE SUPPLIER, MORGAN ADVANCED CERAMICS, FOR THE DEMODULATOR HOUSING (IMPLANT ELECTRONICS CASE).