HIRESOLUTION BIONIC EAR SYSTEM
FDA premarket approval P960058/S087 · decided 2010-12-14
Approval details
- PMA number
- P960058
- Supplement
- S087
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HIRESOLUTION BIONIC EAR SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics
- Date received
- 2010-10-22
- Decision date
- 2010-12-14
- Days to decision
- 53 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- APPROVAL FOR A NEW VERSION OF HEADPIECE, CALLED THE UNIVERSAL HEADPIECE (UHP). THIS CHANGE IS BEING MADE TO PROVIDE A SINGLE HEADPIECE THAT CAN BE USED UNIVERSALLY WITH THE BODY-WORN AND BEHIND-THE-EAR SOUND PROCESSORS AS PART OF A COCHLEAR IMPLANT SYSTEM.
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