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 | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM |
Generic Name | Implant, cochlear |
Applicant | Cochlear Americas 10350 Park Meadows Drive Lone Tree, CO 80124 |
PMA Number | P970051 |
Supplement Number | S019 |
Date Received | 10/23/2001 |
Decision Date | 03/21/2002 |
Product Code |
MCM |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE SP-10 BEHIND-THE-EAR SPEECH PROCESSOR WITH ACE, CIS AND SPEAK SPEECH CODING STRATEGIES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ESPRIT3G AND IS INTENDED TO BE USED WITH THE CI24M, CI24R(ST) AND CI24R(CS) COCHLEAR IMPLANTS. |
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