Infuse Bone Graft/Medtronic Interbody Fusion

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction

FDA Premarket Approval P000058 S076

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

Modifications to the post-approval stability protocol for the drug component of infuse bone graft

DeviceInfuse Bone Graft/Medtronic Interbody Fusion
Classification NameFiller, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction
Generic NameFiller, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction
ApplicantMedtronic Sofamor Danek USA, Inc.
Date Received2019-10-31
Decision Date2019-11-29
PMAP000058
SupplementS076
Product CodeNEK
Advisory CommitteeOrthopedic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place memphis, TN 38132

Supplemental Filings

Supplement NumberDateSupplement Type
P000058Original Filing
S076 2019-10-31 30-day Notice
S075 2019-09-25 30-day Notice
S074
S073
S072 2019-06-28 30-day Notice
S071 2018-10-17 Normal 180 Day Track
S070 2018-10-02 30-day Notice
S069 2018-08-02 30-day Notice
S068 2017-11-13 30-day Notice
S067 2017-05-23 30-day Notice
S066
S065 2017-04-28 Normal 180 Day Track
S064 2017-02-03 30-day Notice
S063 2017-01-23 30-day Notice
S062 2016-08-31 30-day Notice
S061 2016-07-11 30-day Notice
S060 2016-06-21 Normal 180 Day Track
S059 2015-04-13 Normal 180 Day Track
S058 2014-10-29 Real-time Process
S057 2014-10-27 Normal 180 Day Track No User Fee
S056 2014-01-27 Normal 180 Day Track
S055
S054 2013-10-25 Real-time Process
S053 2013-02-26 30-day Notice
S052 2013-01-14 30-day Notice
S051 2012-12-21 30-day Notice
S050 2012-08-21 135 Review Track For 30-day Notice
S049 2011-12-19 Normal 180 Day Track
S048 2011-10-20 Special (immediate Track)
S047 2011-10-04 135 Review Track For 30-day Notice
S046 2011-08-26 Real-time Process
S045 2011-08-19 Special (immediate Track)
S044 2011-06-16 135 Review Track For 30-day Notice
S043 2011-02-15 135 Review Track For 30-day Notice
S042 2011-01-13 30-day Notice
S041 2010-09-30 135 Review Track For 30-day Notice
S040 2010-09-30 135 Review Track For 30-day Notice
S039 2010-09-01 Normal 180 Day Track No User Fee
S038 2010-06-03 135 Review Track For 30-day Notice
S037 2010-05-14 Normal 180 Day Track No User Fee
S036 2010-02-24 Special (immediate Track)
S035
S034 2009-09-01 135 Review Track For 30-day Notice
S033 2009-03-25 135 Review Track For 30-day Notice
S032 2009-03-16 Special (immediate Track)
S031 2008-12-23 Real-time Process
S030 2008-11-21 135 Review Track For 30-day Notice
S029 2008-08-29 135 Review Track For 30-day Notice
S028 2008-01-14 135 Review Track For 30-day Notice
S027 2007-11-16 Normal 180 Day Track No User Fee
S026 2007-11-06 Normal 180 Day Track No User Fee
S025 2007-07-31 135 Review Track For 30-day Notice
S024
S023 2007-04-06 135 Review Track For 30-day Notice
S022 2007-03-05 Normal 180 Day Track
S021 2006-12-22 135 Review Track For 30-day Notice
S020 2006-10-27 Normal 180 Day Track
S019 2006-10-12 Special (immediate Track)
S018
S017 2005-02-22 Real-time Process
S016 2005-02-04 135 Review Track For 30-day Notice
S015 2004-11-15 Real-time Process
S014 2004-09-17 135 Review Track For 30-day Notice
S013
S012
S011
S010 2004-05-20 Real-time Process
S009 2004-04-20 Real-time Process
S008 2004-03-19 Special (immediate Track)
S007 2004-03-04 Special (immediate Track)
S006 2003-08-26 Normal 180 Day Track No User Fee
S005 2003-08-22 Normal 180 Day Track No User Fee
S004 2003-07-01 Normal 180 Day Track
S003 2002-12-16 Normal 180 Day Track
S002
S001

NIH GUDID Devices

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