PMA P960058S106

Device: HIRESOLUTION BIONIC EAR SYSTEM WITH THE NAIDA CI AQUACASE
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S106
Product code: MCM
Decision date: 2014-09-10
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR THE NAIDA CI AQUACASE FOR USE WITH THE NAIDA CI Q70 SOUND PROCESSOR. THE NAIDA CI AQUACASE IS AN ACCESSORY TO THE HIRESOLUTION BIONIC EAR SYSTEM.

Current openFDA PMA Record#

Device: HIRESOLUTION BIONIC EAR SYSTEM WITH THE NAIDA CI AQUACASE
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S106
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2014-09-10
Decision code: APPR
Date received: 2013-12-13
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE NAIDA CI AQUACASE FOR USE WITH THE NAIDA CI Q70 SOUND PROCESSOR. THE NAIDA CI AQUACASE IS AN ACCESSORY TO THE HIRESOLUTION BIONIC EAR SYSTEM.