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 COCHLEAR IMPLANT SYSTEM |
Generic Name | Implant, cochlear |
Applicant | Cochlear Americas 10350 Park Meadows Drive Lone Tree, CO 80124 |
PMA Number | P970051 |
Supplement Number | S104 |
Date Received | 01/16/2013 |
Decision Date | 10/23/2013 |
Product Code |
MCM |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE FOLLOWING CHANGES: A MODIFICATION TO THE FREEDOM SOUND PROCESSOR, A CHANGE IN THE FREEDOM BODYWORN CABLE O-RING, A CHANGE TO FREEDOM BODYWORN CABLE CLIP, A CHANGE TO THE FREEDOM BATTERY PACK, A CHANGE TO THE FREEDOM RECHARGEABLE BATTERY,AND A MODIFICATION OF THE SURGICAL TOOL KIT INSTRUCTIONS FOR THE CI24RE AND CI422 SERIES IMPLANTS. |
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