PMA P090018S041

Device: Esteem® Totally Implantable Hearing System
Applicant: Envoy Medical Corporation
PMA number: P090018
Supplement: S041
Product code: OAF
Decision date: 2022-08-24
Generic name: Implant, hearing, active, middle ear, totally implanted
Approval order statement: Approval of final labeling changes for the post-approval study (PAS) referenced above. The updates to the final PAS labeling have been submitted to comply with the conditions of approval outlined in our approval order for P090018.

Current openFDA PMA Record#

Device: Esteem® Totally Implantable Hearing System
Applicant: Envoy Medical Corporation
PMA number: P090018
Supplement: S041
Product code: OAF
Generic name: Implant, hearing, active, middle ear, totally implanted
Decision date: 2022-08-24
Decision code: APPR
Date received: 2022-03-23
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - PAS
Approval order statement: Approval of final labeling changes for the post-approval study (PAS) referenced above. The updates to the final PAS labeling have been submitted to comply with the conditions of approval outlined in our approval order for P090018.