PMA P960058S033

Device: HIRESOLUTION BIONIC EAR SYSTEM
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S033
Product code: MCM
Decision date: 2004-02-18
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR A NEW AURIA (BEHIND-THE-EAR) ACCESSORY, CALLED THE AURIA T-COIL. THE ACCESSORY PROVIDES AURIA USERS AN OPTIONAL INTERFACE FOR TELEPHONES AND INDUCTION LOOP-BASED ASSISTIVE LISTENING SYSTEM.

Current openFDA PMA Record#

Device: HIRESOLUTION BIONIC EAR SYSTEM
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S033
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2004-02-18
Decision code: APPR
Date received: 2004-02-09
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A NEW AURIA (BEHIND-THE-EAR) ACCESSORY, CALLED THE AURIA T-COIL. THE ACCESSORY PROVIDES AURIA USERS AN OPTIONAL INTERFACE FOR TELEPHONES AND INDUCTION LOOP-BASED ASSISTIVE LISTENING SYSTEM.