MULTI-STRATEGY COCHLEAR IMPLANT-PLATINUM BTE SOUND PROCESSOR (PEDIATRIC)
FDA premarket approval P960058/S015 · decided 2001-01-12
Approval details
- PMA number
- P960058
- Supplement
- S015
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MULTI-STRATEGY COCHLEAR IMPLANT-PLATINUM BTE SOUND PROCESSOR (PEDIATRIC)
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics
- Date received
- 2000-11-16
- Decision date
- 2001-01-12
- Days to decision
- 57 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- APPROVAL FOR INCORPORATION OF THE SIZE-REDUCED SPEECH PROCESSOR TO BE WORN BEHIND THE EAR, KNOWN AS THE PLATINUM BTE(TM) SOUND PROCESSOR. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CLARION(R) MULTI-STRATEGY COCHLEAR IMPLANT PLATINUM BTE(TM) SOUND PROCESSOR. THE DEVICE IS INDICATED TO RESTORE A LEVEL OF AUDITORY SENSATION TO INDIVIDUALS WITH PROFOUND SENSORINEURAL DEAFNESS VIA ELECTRICAL STIMULATION OF THE AUDITORY NERVE. CHILDREN: 1) TWO YEARS OF AGE THROUGH 17 YEARS, IF X-RA
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