PMA P010023S005
- Device
- MAXUM SYSTEM
- Applicant
- Ototronix, LLC
- PMA number
- P010023
- Supplement
- S005
- Product code
- MPV
- Decision date
- 2010-09-10
- Generic name
- Implant, hearing, active, middle ear, partially implanted
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE CHANGE TO BIOTEST LABORATORIS, INC. IN MINNEAPOLIS, MINNESOTA.
Current openFDA PMA Record#
- Device
- MAXUM SYSTEM
- Applicant
- Ototronix, LLC
- PMA number
- P010023
- Supplement
- S005
- Product code
- MPV
- Generic name
- Implant, hearing, active, middle ear, partially implanted
- Decision date
- 2010-09-10
- Decision code
- APPR
- Date received
- 2010-07-27
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE CHANGE TO BIOTEST LABORATORIS, INC. IN MINNEAPOLIS, MINNESOTA.