PMA P960058S029

Device: CLARION CII BIONIC EAR SYSTEM
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S029
Product code: MCM
Decision date: 2003-02-04
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR AN OPTIONAL, ADJUNCT SOFTWARE [NEURAL RESPONSE IMAGING (NRI)] TO IMPLEMENT A CAPABILITY TO MEASURE AND RECORD A NEURAL RESPONSE USING THE SIGNAL GENERATED AND DETECTED BY THE IMPLANT ELECTRONICS.

Current openFDA PMA Record#

Device: CLARION CII BIONIC EAR SYSTEM
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S029
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2003-02-04
Decision code: APPR
Date received: 2003-01-13
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR AN OPTIONAL, ADJUNCT SOFTWARE [NEURAL RESPONSE IMAGING (NRI)] TO IMPLEMENT A CAPABILITY TO MEASURE AND RECORD A NEURAL RESPONSE USING THE SIGNAL GENERATED AND DETECTED BY THE IMPLANT ELECTRONICS.