PMA P960058S102

Device: HIRESOLUTION BIONIC EAR SYSTEM WITH NAIDA CI Q70 SOUND PROCESSOR
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S102
Product code: MCM
Decision date: 2013-08-19
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR THE NAIDA CI Q70 SOUND PROCESSOR, A SMALLER BEHIND THE EAR (BTE) SOUND PROCESSOR THAT HAS WIRELESS CONNECTIVITY. THE SUPPLEMENT ALSO INCLUDES A COMPLEMENTARY SET OF ACCESSORIES, A NEW CLINICIANS PROGRAMMING INTERFACE, AND A NEW VERSION OF THE SOUNDWAVE FITTING SOFTWARE.

Current openFDA PMA Record#

Device: HIRESOLUTION BIONIC EAR SYSTEM WITH NAIDA CI Q70 SOUND PROCESSOR
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S102
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2013-08-19
Decision code: APPR
Date received: 2013-02-04
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE NAIDA CI Q70 SOUND PROCESSOR, A SMALLER BEHIND THE EAR (BTE) SOUND PROCESSOR THAT HAS WIRELESS CONNECTIVITY. THE SUPPLEMENT ALSO INCLUDES A COMPLEMENTARY SET OF ACCESSORIES, A NEW CLINICIANS PROGRAMMING INTERFACE, AND A NEW VERSION OF THE SOUNDWAVE FITTING SOFTWARE.