PMA P960058S061

Device: HARMONY HIRESOLUTION BIONIC EAR SYSTEM
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S061
Product code: MCM
Decision date: 2008-04-21
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR AN UPDATED CHANGE TO THE INSTRUCTIONS FOR USE (IFU) FOR THE ICONNECT, AS ACCESSORY TO THE ADVANCED BIONICS BEHIND-THE-EAR SPEECH PROCESSORS, AS FOLLOWS: FROM: ?THE AURIA ICONNECT CAN ONLY USE A STANDARD SIZE 10 BATTERY. DO NOT USE ANY OTHER BATTERY.? TO: ?ONLY ZENIPOWER SIZE 10A BATTERIES FROM ADVANCED BIONICS ARE CERTIFIED FOR USE WITH THE ICONNECT. PLEASE CONTACT ADVANCED BIONICS OF ITS AUTHORIZED DISTRIBUTORS TO PURCHASE THESE BATTERIES. OTHER BATTERIES MAY NOT PROVIDE SUFFICIENT BATTERY LIFE WHEN USED WITH THE ICONNECT.?

Current openFDA PMA Record#

Device: HARMONY HIRESOLUTION BIONIC EAR SYSTEM
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S061
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2008-04-21
Decision code: APPR
Date received: 2008-03-24
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR AN UPDATED CHANGE TO THE INSTRUCTIONS FOR USE (IFU) FOR THE ICONNECT, AS ACCESSORY TO THE ADVANCED BIONICS BEHIND-THE-EAR SPEECH PROCESSORS, AS FOLLOWS: FROM: ?THE AURIA ICONNECT CAN ONLY USE A STANDARD SIZE 10 BATTERY. DO NOT USE ANY OTHER BATTERY.? TO: ?ONLY ZENIPOWER SIZE 10A BATTERIES FROM ADVANCED BIONICS ARE CERTIFIED FOR USE WITH THE ICONNECT. PLEASE CONTACT ADVANCED BIONICS OF ITS AUTHORIZED DISTRIBUTORS TO PURCHASE THESE BATTERIES. OTHER BATTERIES MAY NOT PROVIDE SUFFICIENT BATTERY LIFE WHEN USED WITH THE ICONNECT.?