PMA P090018S020

Device: ESTEEM SYSTEM
Applicant: Envoy Medical Corporation
PMA number: P090018
Supplement: S020
Product code: OAF
Decision date: 2013-06-06
Classification: Implant, Hearing, Active, Middle Ear, Totally Implanted
Generic name: Implant, hearing, active, middle ear, totally implanted
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.

Current openFDA PMA Record#

Device: ESTEEM SYSTEM
Applicant: Envoy Medical Corporation
PMA number: P090018
Supplement: S020
Product code: OAF
Generic name: Implant, hearing, active, middle ear, totally implanted
Decision date: 2013-06-06
Decision code: APPR
Date received: 2013-05-01
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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.