NUCLEUS COCHLEAR IMPLANT SYSTEM
FDA premarket approval P970051/S091 · decided 2013-05-28
Approval details
- PMA number
- P970051
- Supplement
- S091
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NUCLEUS COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2012-07-13
- Decision date
- 2013-05-28
- Days to decision
- 319 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- 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 THEI
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