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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceNUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM
Generic NameImplant, cochlear
ApplicantCochlear Americas
10350 Park Meadows Drive
Lone Tree, CO 80124
PMA NumberP840024
Supplement NumberS063
Date Received04/25/1996
Decision Date06/20/1996
Product Code MCM 
Advisory Committee Ear Nose & Throat
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR REVISIONS TO THE WARNINGS SECTION IN THE PACAKGE INSERT AND PATIENT IDENTIFICATION CARD FOR THE NUCLEUS 22 COCHLEAR IMPLANT SYSTEM. THE REVISIONS CLARIFY THE WARNING ON THE USE OF MONOPOLAR ELECTROSURGICAL INSTRUMENTS ON IMPLANT PATIENTS AND PROVIDES USE OF MONOPOLAR ELECTROSURGICAL INSTRUMENTS ON IMPLANT PATIENTS AND PROVIDES ADDTIONIAL INSTRUCTIONS FOR THE SAFE USE OF BIPOLAR INSTRUMENTS
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