EXOGEN 2000+ AND EXOGEN 3000

Stimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep

FDA Premarket Approval P900009 S018

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 two design and component changes: 1) changes to exogen 2000+ printed circuit board to implement corrective action for field failure and returns. This corrective action involves two design changes: i) replace 2 diodes on te printed circuit board with light emitting diodes. Ii) add a 1000 pf capacitor to reduce electrical noise. 2) replace both exogen 2000+ and exogen 3000 transducer cables with a more cost effective model.

DeviceEXOGEN 2000+ AND EXOGEN 3000
Classification NameStimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
Generic NameStimulator, Ultrasound And Muscle, For Use Other Than Applying Therapeutic Deep
ApplicantBIOVENTUS LLC
Date Received2004-01-29
Decision Date2004-03-12
PMAP900009
SupplementS018
Product CodeLPQ
Advisory CommitteeOrthopedic
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
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
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
M937710346601 P900009 035

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