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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameCALRION CII BIONIC EAR SYSTEM (ADULT)
Classification Nameimplant, cochlear
Generic Namecochlear implant (adult)
ApplicantADVANCED BIONICS CORP.
PMA NumberP940022
Supplement NumberS027
Date Received10/25/2002
Decision Date11/06/2002
Product Code
MCM[ Registered Establishments with MCM ]
Advisory Committee Ear Nose & Throat
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a revision to the package insert (document number 9196252-001) that modified the percentage of patients who preferred high resolution sound processing to conventional sound processing. This modification is based on updated data received from patients at the 12-month follow-up visit which showed that three of the five patients who originally preferred their conventional strategy at the three-month experimental strategy visit switched their preference to hires. Thus, 48 of 50 patients (96%) ultimately preferred hires.
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