AUDALLION BEAMFORMER
FDA premarket approval P840024/S077 · decided 1998-09-25
Approval details
- PMA number
- P840024
- Supplement
- S077
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AUDALLION BEAMFORMER
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 1998-09-21
- Decision date
- 1998-09-25
- Days to decision
- 4 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Approval of four minor design changes to the Audallion Beamformer Noise Reduction System: 1)switch on/off circuit improvements 2) replacement of the LC filter with an RC filter 3) battery spring design change 4) a minor software change pertaining to the volume default. With reference to item 1), the resistor value change would improve the switch on/off of the Audiallion regarding item 2), the RC filter will improve the rejction of the overall RF interference. For item 3), changing the battery sp
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