MAXUM System

FDA Premarket Approval P010023 S014

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.

Pre-market Approval Supplement Details

An ethylene oxide (eo) sterilization process change for the implantable magnet canister assembly

• Device: MAXUM System
• Generic Name: Implant, Hearing, Active, Middle Ear, Partially Implanted
• Applicant: OTOTRONIX, LLC
• Date Received: 2020-09-28
• Decision Date: 2020-10-28
• PMA: P010023
• Supplement: S014
• Product Code: MPV
• Advisory Committee: Ear Nose & Throat
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: OTOTRONIX, LLC 26620 I-45 North houston, TX 77386

Supplemental Filings

Supplement Number	Date	Supplement Type
P010023		Original Filing
S014	2020-09-28	30-day Notice
S013	2015-09-15	135 Review Track For 30-day Notice
S012	2015-09-09	Normal 180 Day Track No User Fee
S011	2014-05-29	Normal 180 Day Track
S010	2013-06-13	Real-time Process
S009	2011-04-27	135 Review Track For 30-day Notice
S008	2010-12-21	30-day Notice
S007	2010-10-25	Normal 180 Day Track
S006	2010-09-15	Normal 180 Day Track No User Fee
S005	2010-07-27	Normal 180 Day Track No User Fee
S004	2010-07-07	Normal 180 Day Track
S003	2010-05-18	135 Review Track For 30-day Notice
S002	2009-08-19	Normal 180 Day Track No User Fee
S001	2001-11-21	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
M737M53031	P010023	000
M737M31991	P010023	000
M737M31101	P010023	000