FDA Premarket Approval P900009 S048

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

Use an additional supplier for the plastic housing components of the main operating unit of the exogen® ultrasound bone healing system.

Generic NameStimulator, Bone Growth, Non-invasive
Date Received2021-12-03
Decision Date2022-01-07
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
S048 2021-12-03 30-day Notice
S047 2021-05-25 Normal 180 Day Track
S046 2021-03-16 30-day Notice
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
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
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
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
S003 1996-01-02 Normal 180 Day Track
S002 1995-12-15 Normal 180 Day Track
S001 1995-02-14 Normal 180 Day Track


Device IDPMASupp
M937710346001 P900009 022
M937710344001 P900009 035
M937710346601 P900009 035

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