HIRESOLUTION BIONIC EAR SYSTEM
FDA premarket approval P960058/S032 · decided 2003-12-16
Approval details
- PMA number
- P960058
- Supplement
- S032
- 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
- 2003-12-09
- Decision date
- 2003-12-16
- Days to decision
- 7 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- APPROVAL FOR AN OPTIONAL ACCESSORY ITEM THAT CAN BE USED WITH THE PLATINUM HEADPIECE AND AURIA HEADPIECE. THIS ITEM, NAMED HEADPIECE SPACER, IS A PASSIVE PIECE OF ELASTOMER INTENDED TO BE PLACED BETWEEN THE HEADPIECE INNER SURFACE AND THE PATIENT'S SCALP. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HIRESOLUTION BIONIC EAR SYSTEM AND IS INDICATED FOR ADULTS WITH POST-LINGUAL ONSET OF SEVERE-TO-PROFOUND HEARING LOSS AND IN CHILDREN WITH PROFOUND HEARING LOSS (12-MONTHS TO 17 YEA
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