PMA P970051S091

Device: NUCLEUS COCHLEAR IMPLANT SYSTEM
Applicant: Cochlear Americas
PMA number: P970051
Supplement: S091
Product code: MCM
Decision date: 2013-05-28
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR THE AQUA ACCESSORY FOR THE NUCLEUS COCHLEAR IMPLANT SYSTEM. THE AQUA ACCESSORY IS A WATER RESISTANT POUCH THAT IS SEALABLE AT ONE END, AND HOLDS THE EXTERNAL NUCLEUS 5 CP810 SOUND PROCESSOR AND COIL. IT MAY BE USED FOR UP TO AN HOUR TO KEEP THE EXTERNAL COMPONENTS DRY DURING USE IN WATER (E.G., SWIMMING). THE AQUA ACCESSORY IS INTENDED FOR UNILATERAL OR BILATERAL USE BY COCHLEAR IMPLANT RECIPIENTS WHO HAVE THE ABILITY TO NOTIFY A CAREGIVER OR THE ABILITY TO REMOVE THE DEVICE ON THEIR OWN, IF THE DEVICE BECOMES HOT OR IF THERE IS A CHANGE IN SOUND QUALITY.

Current openFDA PMA Record#

Device: NUCLEUS COCHLEAR IMPLANT SYSTEM
Applicant: Cochlear Americas
PMA number: P970051
Supplement: S091
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2013-05-28
Decision code: APPR
Date received: 2012-07-13
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE AQUA ACCESSORY FOR THE NUCLEUS COCHLEAR IMPLANT SYSTEM. THE AQUA ACCESSORY IS A WATER RESISTANT POUCH THAT IS SEALABLE AT ONE END, AND HOLDS THE EXTERNAL NUCLEUS 5 CP810 SOUND PROCESSOR AND COIL. IT MAY BE USED FOR UP TO AN HOUR TO KEEP THE EXTERNAL COMPONENTS DRY DURING USE IN WATER (E.G., SWIMMING). THE AQUA ACCESSORY IS INTENDED FOR UNILATERAL OR BILATERAL USE BY COCHLEAR IMPLANT RECIPIENTS WHO HAVE THE ABILITY TO NOTIFY A CAREGIVER OR THE ABILITY TO REMOVE THE DEVICE ON THEIR OWN, IF THE DEVICE BECOMES HOT OR IF THERE IS A CHANGE IN SOUND QUALITY.