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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
Classification Nameimplant, cochlear
Generic Nameimplant, cochlear
Applicant
Cochlear Americas
13059 e peakview ave
centennial, CO 80111
PMA NumberP890027
Supplement NumberS032
Date Received04/25/1996
Decision Date06/13/1996
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR REVISIONS TO THE WARNING SECTION IN THE PACKAGE 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 ADD'L INSTRUCTIONS FOR THE SAFE USE OF BIPOLAR INSTRUMENTS
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