Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | NUCLEUS COCHLEAR IMPLANT SYSTEM |
Generic Name | Implant, cochlear |
Applicant | Cochlear Americas 10350 Park Meadows Drive Lone Tree, CO 80124 |
PMA Number | P970051 |
Supplement Number | S091 |
Date Received | 07/13/2012 |
Decision Date | 05/28/2013 |
Product Code |
MCM |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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. |
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