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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.
 
DeviceESTEEM IMPLANTABLE HEARING SYSTEM
Generic NameImplant, hearing, active, middle ear, totally implanted
ApplicantENVOY MEDICAL CORPORATION
4875 WHITE BEAR PARKWAY
WHITE BEAR LAKE, MN 55110
PMA NumberP090018
Supplement NumberS019
Date Received04/19/2013
Decision Date05/17/2013
Product Code OAF 
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 THE FOLLOWING: 1) REVISIONS TO THE INSTRUCTIONS FOR USE FOR THE IMPLANTING SURGEON; 2) A MANUAL TO INFORM AUDIOLOGISTS ON THE PROGRAMMING OF THE ESTEEM SYSTEM; AND 3) FOR MAKING MANUALS, WHICH ARE MADE REDUNDANT BY THE FORMER LABELING CHANGES, OBSOLETE.
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