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 | CALRION CII BIONIC EAR SYSTEM (ADULT) |
Generic Name | Implant, cochlear |
Applicant | ADVANCED BIONICS CORP. 12740 SAN FERNANDO RD. SYLMAR, CA 91342 |
PMA Number | P940022 |
Supplement Number | S027 |
Date Received | 10/25/2002 |
Decision Date | 11/06/2002 |
APCB Date
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10/18/2002 |
Product Code |
MCM |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
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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