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

DeviceMAXUM System
Generic NameImplant, Hearing, Active, Middle Ear, Partially Implanted
ApplicantOTOTRONIX, LLC
Date Received2020-09-28
Decision Date2020-10-28
PMAP010023
SupplementS014
Product CodeMPV 
Advisory CommitteeEar Nose & Throat
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address OTOTRONIX, LLC 26620 I-45 North houston, TX 77386

Supplemental Filings

Supplement NumberDateSupplement Type
P010023Original 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

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