| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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| Device | AUDALLION BEAMFORMER |
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| Generic Name | Implant, cochlear |
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| Applicant | Cochlear Americas
10350 Park Meadows Drive
Lone Tree, CO 80124 |
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| PMA Number | P840024 |
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| Supplement Number | S077 |
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| Date Received | 09/21/1998 |
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| Decision Date | 09/25/1998 |
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| Product Code |
MCM |
| Advisory Committee |
Ear Nose & Throat |
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| Supplement Type | Real-Time Process |
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| Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order 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 spring design will ensure the proper battery contact position, reducing the likelihood of battery discharge. Item 4) pertains to a software change that will retain the user's volume setting whenever s/he cycles through the available procesor settings on the Audallion, enabling the device to be more user friendly. |
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