PMA P940022S006

Device: CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT (ADULT) FLEX LEAD ELECTRODE
Applicant: Advanced Bionics Corp.
PMA number: P940022
Supplement: S006
Decision date: 1998-09-04
Approval order statement: Approval for a revision to the INFORMATION GUIDE in which the question and answer regarding restrictions on physical activities on page 31 have been deleted and a sticker containing the following questioin and answer has been afixed to page 29: "Are there any restrictions on physical activities with CLARION?" "CLARION is engineered to last a lifetime and is capable of withstanding the effects of running, exercise and normal activity. For children engaging in physical activities that include the possibility of impact to the implant site, extra precautions should be taken, sucha s using a protective helmet to reduce the risk of device failure."

Current openFDA PMA Record#

Device: CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT (ADULT) FLEX LEAD ELECTRODE
Applicant: Advanced Bionics Corp.
PMA number: P940022
Supplement: S006
Decision date: 1998-09-04
Decision code: APPR
Date received: 1998-06-30
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for a revision to the INFORMATION GUIDE in which the question and answer regarding restrictions on physical activities on page 31 have been deleted and a sticker containing the following questioin and answer has been afixed to page 29: "Are there any restrictions on physical activities with CLARION?" "CLARION is engineered to last a lifetime and is capable of withstanding the effects of running, exercise and normal activity. For children engaging in physical activities that include the possibility of impact to the implant site, extra precautions should be taken, sucha s using a protective helmet to reduce the risk of device failure."