PMA P960058S073

Device: HARMONY HIRESOLUTION BIONIC EAR SYSTEM
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S073
Product code: MCM
Decision date: 2008-12-09
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR A NEW REPAIR SERVICE FOR SPEECH PROCESSORS WITH ASSOCIATED LETTERS TO PATIENTS (ADULT, PEDIATRIC) WHICH ACCOMPANIES THE REPLACEMENT PROCESSOR.

Current openFDA PMA Record#

Device: HARMONY HIRESOLUTION BIONIC EAR SYSTEM
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S073
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2008-12-09
Decision code: APPR
Date received: 2008-11-10
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR A NEW REPAIR SERVICE FOR SPEECH PROCESSORS WITH ASSOCIATED LETTERS TO PATIENTS (ADULT, PEDIATRIC) WHICH ACCOMPANIES THE REPLACEMENT PROCESSOR.