PMA P010023S003

Device: MAXUM SYSTEM
Applicant: Ototronix, LLC
PMA number: P010023
Supplement: S003
Product code: MPV
Decision date: 2010-09-30
Generic name: Implant, hearing, active, middle ear, partially implanted
Approval order statement: APPROVAL FOR A CHANGE IN THE MAGNET CANISTER MANUFACTURING PROCESS/INSPECTION, AND THE RE-QUALIFICATION OF THE MAGNETIZATION VENDOR AT THE VENDOR¿S NEW FACILITY LOCATION.

Current openFDA PMA Record#

Device: MAXUM SYSTEM
Applicant: Ototronix, LLC
PMA number: P010023
Supplement: S003
Product code: MPV
Generic name: Implant, hearing, active, middle ear, partially implanted
Decision date: 2010-09-30
Decision code: APPR
Date received: 2010-05-18
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A CHANGE IN THE MAGNET CANISTER MANUFACTURING PROCESS/INSPECTION, AND THE RE-QUALIFICATION OF THE MAGNETIZATION VENDOR AT THE VENDOR¿S NEW FACILITY LOCATION.