EXOGEN Ultrasound Bone Healing System

FDA Premarket Approval P900009 S046

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

To use an additional supplier for the ultrasound gel provided with the exogen ultrasound bone healing system

DeviceEXOGEN Ultrasound Bone Healing System
Generic NameStimulator, Bone Growth, Non-invasive
ApplicantBIOVENTUS LLC
Date Received2021-03-16
Decision Date2021-04-14
PMAP900009
SupplementS046
Product CodeLOF 
Advisory CommitteeOrthopedic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address BIOVENTUS LLC 4721 Emperor Blvd Suite 100 durham, NC 27703

Supplemental Filings

Supplement NumberDateSupplement Type
P900009Original Filing
S046 2021-03-16 30-day Notice
S045
S044 2019-06-25 Normal 180 Day Track
S043 2018-04-30 30-day Notice
S042 2017-08-14 30-day Notice
S041 2016-12-13 30-day Notice
S040
S039 2015-03-02 30-day Notice
S038 2014-11-17 30-day Notice
S037 2014-07-22 30-day Notice
S036 2013-08-22 Normal 180 Day Track No User Fee
S035 2013-07-15 Normal 180 Day Track
S034
S033 2012-05-09 30-day Notice
S032 2010-02-24 30-day Notice
S031 2009-06-09 Normal 180 Day Track No User Fee
S030 2008-12-23 135 Review Track For 30-day Notice
S029 2008-11-28 30-day Notice
S028 2007-07-20 30-day Notice
S027 2007-07-10 Real-time Process
S026
S025 2007-02-22 135 Review Track For 30-day Notice
S024 2006-10-02 30-day Notice
S023 2006-05-15 Real-time Process
S022 2005-12-16 Normal 180 Day Track
S021 2005-08-01 Normal 180 Day Track
S020 2005-04-29 30-day Notice
S019 2004-03-05 Real-time Process
S018 2004-01-29 Real-time Process
S017 2003-03-03 Special (immediate Track)
S016 2002-12-20 Real-time Process
S015 2001-12-13 Normal 180 Day Track
S014 2001-12-07 Real-time Process
S013 2001-04-30 Normal 180 Day Track
S012 2000-10-12 Normal 180 Day Track
S011 2000-07-11 Normal 180 Day Track
S010 2000-04-14 Real-time Process
S009 2000-04-03 Normal 180 Day Track
S008 1999-10-27 Normal 180 Day Track
S007 1999-07-07 Real-time Process
S006 1998-07-02 Panel Track
S005
S004
S003 1996-01-02 Normal 180 Day Track
S002 1995-12-15 Normal 180 Day Track
S001 1995-02-14 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
M937710346001 P900009 022
M937710344001 P900009 035

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