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. |
|
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 | S034 |
Date Received | 09/23/2005 |
Decision Date | 10/21/2005 |
Product Code |
MCM |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR AN ALTERNATIVE CABLE AND CONNECTOR (ALSO KNOWN AS SHOE) TO BE USED WITH THE PREVIOUSLY APPROVED NUCLEUS FREEDOM BODYWORN PROCESSOR. THE ALTERNATIVE CABLE/SHOE HAS BEEN DESIGNED TO BE COMPATIBLE WITH WIRELESS FM COMMUNICATION SYSTEMS MANUFACTURED BY PHONAK HEARING SYSTEMS. |
|
|