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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 SYSTEM
Generic NameImplant, hearing, active, middle ear, totally implanted
ApplicantENVOY MEDICAL CORPORATION
4875 WHITE BEAR PARKWAY
WHITE BEAR LAKE, MN 55110
PMA NumberP090018
Supplement NumberS020
Date Received05/01/2013
Decision Date06/06/2013
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
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR ADDITION OF TECHNICAL NOTES TO EXPAND UPON THE INFORMATION IN THE AUDIOLOGISTS MANUAL AND TO REMIND SURGEONS AND AUDIOLOGISTS OF THE IMPORTANCE OF REPORTING SIGNIFICANT INJURIES TO CRANIAL NERVE VII VIA THE MEDICAL DEVICE REPORTING SYSTEM.
Post-Approval StudyShow Report Schedule and Study Progress
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