Premarket Approval (PMA)

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.

• Device: ESTEEM
• Generic Name: Implant, hearing, active, middle ear, totally implanted
• Applicant: Envoy Medical Corporation; 4875 White Bear Pkwy.; White Bear Lake, MN 55110
• PMA Number: P090018
• Supplement Number: S018
• Date Received: 08/29/2012
• Decision Date: 09/28/2012
• Product Code: OAF
• Advisory Committee: Ear Nose & Throat
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
CHANGE TO THE EAR INSERT TUBE CLEANING PROCESS.