PMA P090018S019

Device: ESTEEM IMPLANTABLE HEARING SYSTEM
Applicant: Envoy Medical Corporation
PMA number: P090018
Supplement: S019
Product code: OAF
Decision date: 2013-05-17
Classification: Implant, Hearing, Active, Middle Ear, Totally Implanted
Generic name: Implant, hearing, active, middle ear, totally implanted
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.

Current openFDA PMA Record#

Device: ESTEEM IMPLANTABLE HEARING SYSTEM
Applicant: Envoy Medical Corporation
PMA number: P090018
Supplement: S019
Product code: OAF
Generic name: Implant, hearing, active, middle ear, totally implanted
Decision date: 2013-05-17
Decision code: APPR
Date received: 2013-04-19
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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.