HARMONY HIRESOLUTION BIONIC EAR SYSTEM
FDA premarket approval P960058/S049 · decided 2006-08-17
Approval details
- PMA number
- P960058
- Supplement
- S049
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HARMONY HIRESOLUTION BIONIC EAR SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics
- Date received
- 2005-12-12
- Decision date
- 2006-08-17
- Days to decision
- 248 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- APPROVAL FOR A MODIFICATION TO THE SOUNDWAVE PROFESSIONAL SUITE SOFTWARE (SOUNDWAVE VERSION 1.4) WHICH IMPLEMENTS AN OPTIONAL FEATURE, KNOWN AS FIDELITY 120, AND ADDS SUPPORT FOR THE AURIA HARMONY SOUND PROCESSOR. THE SOFTWARE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SOUNDWAVE PROFESSIONAL SUITE VERSION 1.4 AND IS INDICATED FOR ADULT PATIENTS AND PEDIATRIC PATIENTS AGED 12-MONTHS THROUGH 17 YEARS, 11-MONTHS. HOWEVER, THE OPTIONAL SOFTWARE CAPABILITY KNOWN AS FIDELITY 120 (SPEECH ENCOD
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