CII BIONIC CAR SYSTEM, HIRES AURIA PROCESSOR AND ACCESSORIES
FDA premarket approval P960058/S031 · decided 2003-06-06
Approval details
- PMA number
- P960058
- Supplement
- S031
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CII BIONIC CAR SYSTEM, HIRES AURIA PROCESSOR AND ACCESSORIES
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics
- Date received
- 2003-05-23
- Decision date
- 2003-06-06
- Days to decision
- 14 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- APPROVAL FOR CHANGES TO THE FOLLOWING PARTS OF THE BEHIND-THE-EAR (BTE) SOUND PROCESSOR: 1) THE TOGGLE SWITCH, 2) THE BTE BATTERY, 3) THE ACCESSORIES AVAILABLE WITH THE CURRENT BTE, 4) THE NEW ACCESSORY ITEMS, 5) THE AURIA HEADPIECE, AND 6) THE ESD WARNING IN THE PACKAGE INSERT.
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