PMA P010023S012

Device: MAXUM SYSTEM
Applicant: Ototronix, LLC
PMA number: P010023
Supplement: S012
Product code: MPV
Decision date: 2016-05-03
Generic name: Implant, hearing, active, middle ear, partially implanted
Approval order statement: Approval for a manufacturing site located at Ototronix LLC, 5000 Township Parkway, St. Paul, Minnesota to perform manufacturing and distribution.

Current openFDA PMA Record#

Device: MAXUM SYSTEM
Applicant: Ototronix, LLC
PMA number: P010023
Supplement: S012
Product code: MPV
Generic name: Implant, hearing, active, middle ear, partially implanted
Decision date: 2016-05-03
Decision code: APPR
Date received: 2015-09-09
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 located at Ototronix LLC, 5000 Township Parkway, St. Paul, Minnesota to perform manufacturing and distribution.