PMA P970051S096

Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Applicant: Cochlear Americas
PMA number: P970051
Supplement: S096
Product code: MCM
Decision date: 2013-08-02
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR THE NUCLEUS 6 COCHLEAR IMPLANT SYSTEM, A NEW SUITE OF EXTERNAL ACCESSORIES AND PROGRAMMING SOFTWARE TO BE USED WITH THE NUCLEUS 24 COCHLEAR IMPLANT, INCLUDING EXTERNAL SOUND PROCESSORS (CP910 AND CP920), USER REMOTE ASSISTANTS (CR210 AND CR230), INTRAOPERATIVE REMOTE ASSISTANT (CR220), AND PROGRAMMING SOFTWARE (CUSTOM SOUND SUITE 4 COMPRISED OF CUSTOM SOUND 4 AND CUSTOM SOUND EP 4).

Current openFDA PMA Record#

Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Applicant: Cochlear Americas
PMA number: P970051
Supplement: S096
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2013-08-02
Decision code: APPR
Date received: 2012-08-27
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE NUCLEUS 6 COCHLEAR IMPLANT SYSTEM, A NEW SUITE OF EXTERNAL ACCESSORIES AND PROGRAMMING SOFTWARE TO BE USED WITH THE NUCLEUS 24 COCHLEAR IMPLANT, INCLUDING EXTERNAL SOUND PROCESSORS (CP910 AND CP920), USER REMOTE ASSISTANTS (CR210 AND CR230), INTRAOPERATIVE REMOTE ASSISTANT (CR220), AND PROGRAMMING SOFTWARE (CUSTOM SOUND SUITE 4 COMPRISED OF CUSTOM SOUND 4 AND CUSTOM SOUND EP 4).