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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
Generic NameImplant, hearing, active, middle ear, totally implanted
ApplicantEnvoy Medical Corporation
4875 White Bear Pkwy.
White Bear Lake, MN 55110
PMA NumberP090018
Supplement NumberS039
Date Received09/05/2019
Decision Date02/24/2020
Product Code OAF 
Advisory Committee Ear Nose & Throat
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the following changes to the post-approval study (i.e., the New Enrollment 2 study, approved under P090018/S030) for your device: (a) use the evaluable bone conduction data at 1 month as a safety endpoint to measure cochlear stability collected from the 45 subjects used for the efficacy endpoints (SRT and WRS), and (b) supplement the AE safety endpoints (SAEs including facial paresis/paralysis at 1 month) with data from a retrospective review of charts from patients not participating in the post-approval study.
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