PMA P090018S034

Device: Esteem
Applicant: Envoy Medical Corporation
PMA number: P090018
Supplement: S034
Product code: OAF
Decision date: 2017-05-24
Classification: Implant, Hearing, Active, Middle Ear, Totally Implanted
Generic name: Implant, hearing, active, middle ear, totally implanted
Approval order statement: Approval for relocation and requalification of the supplier for the seam welding and laser marking processes for the Esteem System Sound Processor, Model 2001.

Current openFDA PMA Record#

Device: Esteem
Applicant: Envoy Medical Corporation
PMA number: P090018
Supplement: S034
Product code: OAF
Generic name: Implant, hearing, active, middle ear, totally implanted
Decision date: 2017-05-24
Decision code: APPR
Date received: 2017-03-13
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for relocation and requalification of the supplier for the seam welding and laser marking processes for the Esteem System Sound Processor, Model 2001.