PMA P940022S014

Device: CLARION(R) MULTI-STRATEGY COCHLEAR IMPLANT(ADULT) HIFOCUS ELECTRODE
Applicant: Advanced Bionics Corp.
PMA number: P940022
Supplement: S014
Product code: MCM
Decision date: 2000-07-13
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR THE CLARION(R) MULTI-STRATEGY COCHLEAR IMPLANT HIFOCUS ELECTRODE FOR POST-LINGUAL SEVERE TO PROFOUND HEARING LOSS WHERE LIMITED BENEFIT HAS BEEN OBTAINED WITH THE USE OF HEARING AIDS.

Current openFDA PMA Record#

Device: CLARION(R) MULTI-STRATEGY COCHLEAR IMPLANT(ADULT) HIFOCUS ELECTRODE
Applicant: Advanced Bionics Corp.
PMA number: P940022
Supplement: S014
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2000-07-13
Decision code: APPR
Date received: 2000-03-22
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE CLARION(R) MULTI-STRATEGY COCHLEAR IMPLANT HIFOCUS ELECTRODE FOR POST-LINGUAL SEVERE TO PROFOUND HEARING LOSS WHERE LIMITED BENEFIT HAS BEEN OBTAINED WITH THE USE OF HEARING AIDS.