SOUNDTECH DIRECT AND MAXUM

FDA Premarket Approval P010023 S013

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

Approval for a test fixture and inspection process change for the magnet canister assembly (mca).

DeviceSOUNDTECH DIRECT AND MAXUM
Generic NameImplant, Hearing, Active, Middle Ear, Partially Implanted
ApplicantOTOTRONIX, LLC
Date Received2015-09-15
Decision Date2016-03-22
PMAP010023
SupplementS013
Product CodeMPV 
Advisory CommitteeEar Nose & Throat
Supplement Type135 Review Track For 30-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

NIH GUDID Devices

Device IDPMASupp
M737M53031 P010023 000
M737M31991 P010023 000
M737M31101 P010023 000
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