| Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device. |
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| Trade Name | NUCLEUS 22 COCHLEAR IMPLANT SYSTEM (ADULTS) |
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| Classification Name | implant, cochlear |
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| Generic Name | cochlear implant (adult) |
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| Applicant | COCHLEAR AMERICAS |
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| PMA Number | P840024 |
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| Supplement Number | S085 |
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| Date Received | 12/06/2002 |
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| Decision Date | 04/02/2003 |
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| Product Code | |
| Advisory Committee |
Ear Nose & Throat |
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| Supplement Type | normal 180 day track |
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| Supplement Reason | change design/components/specifications - software |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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Approval Order Statement
Approval for the new r126 version 2 software and if6 card. |
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