PMA P960058S031

Device: CII BIONIC CAR SYSTEM, HIRES AURIA PROCESSOR AND ACCESSORIES
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S031
Product code: MCM
Decision date: 2003-06-06
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR CHANGES TO THE FOLLOWING PARTS OF THE BEHIND-THE-EAR (BTE) SOUND PROCESSOR: 1) THE TOGGLE SWITCH, 2) THE BTE BATTERY, 3) THE ACCESSORIES AVAILABLE WITH THE CURRENT BTE, 4) THE NEW ACCESSORY ITEMS, 5) THE AURIA HEADPIECE, AND 6) THE ESD WARNING IN THE PACKAGE INSERT.

Current openFDA PMA Record#

Device: CII BIONIC CAR SYSTEM, HIRES AURIA PROCESSOR AND ACCESSORIES
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S031
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2003-06-06
Decision code: APPR
Date received: 2003-05-23
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR CHANGES TO THE FOLLOWING PARTS OF THE BEHIND-THE-EAR (BTE) SOUND PROCESSOR: 1) THE TOGGLE SWITCH, 2) THE BTE BATTERY, 3) THE ACCESSORIES AVAILABLE WITH THE CURRENT BTE, 4) THE NEW ACCESSORY ITEMS, 5) THE AURIA HEADPIECE, AND 6) THE ESD WARNING IN THE PACKAGE INSERT.