Infuse Bone Graft

FDA Premarket Approval P000054 S059

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

Optimization of the pre-sterilization phase set points of in-process autoclave cycles and addition of a second tyvek wrapping for equipment, parts, and components sterilized in the in-process autoclaves.

DeviceInfuse Bone Graft
Generic NameFiller, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction
ApplicantMedtronic Sofamor Danek USA, Inc.
Date Received2020-06-11
Decision Date2020-07-10
PMAP000054
SupplementS059
Product CodeMPW 
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
P000054Original Filing
S059 2020-06-11 30-day Notice
S058 2019-11-04 30-day Notice
S057 2019-10-31 30-day Notice
S056 2019-09-25 30-day Notice
S055
S054
S053 2019-06-28 30-day Notice
S052 2018-10-17 Normal 180 Day Track
S051 2018-10-02 30-day Notice
S050 2018-08-02 30-day Notice
S049 2017-11-13 30-day Notice
S048 2017-05-23 30-day Notice
S047
S046 2017-02-03 30-day Notice
S045 2017-01-23 30-day Notice
S044 2016-06-21 Normal 180 Day Track
S043 2014-10-27 Normal 180 Day Track No User Fee
S042 2014-01-27 Normal 180 Day Track
S041
S040 2013-10-25 Real-time Process
S039 2013-03-07 Special (immediate Track)
S038 2013-02-26 30-day Notice
S037 2013-01-14 30-day Notice
S036 2012-12-21 30-day Notice
S035 2012-08-21 135 Review Track For 30-day Notice
S034 2011-12-19 Normal 180 Day Track
S033 2011-10-20 Special (immediate Track)
S032 2011-10-04 135 Review Track For 30-day Notice
S031 2011-06-16 135 Review Track For 30-day Notice
S030 2011-02-15 135 Review Track For 30-day Notice
S029 2011-01-13 30-day Notice
S028 2010-09-30 135 Review Track For 30-day Notice
S027 2010-09-30 135 Review Track For 30-day Notice
S026 2010-09-01 Normal 180 Day Track No User Fee
S025 2010-06-03 135 Review Track For 30-day Notice
S024 2010-02-24 Special (immediate Track)
S023 2009-09-01 135 Review Track For 30-day Notice
S022 2009-03-25 135 Review Track For 30-day Notice
S021 2009-03-16 Special (immediate Track)
S020 2008-12-23 Real-time Process
S019 2008-11-21 135 Review Track For 30-day Notice
S018 2008-08-29 135 Review Track For 30-day Notice
S017 2008-01-14 135 Review Track For 30-day Notice
S016 2007-11-16 Normal 180 Day Track No User Fee
S015 2007-11-06 Normal 180 Day Track No User Fee
S014
S013 2007-07-31 135 Review Track For 30-day Notice
S012
S011 2007-04-06 135 Review Track For 30-day Notice
S010 2006-12-22 135 Review Track For 30-day Notice
S009 2006-10-27 Normal 180 Day Track
S008 2006-10-12 Special (immediate Track)
S007
S006 2005-02-22 Real-time Process
S005 2005-02-04 135 Review Track For 30-day Notice
S004 2005-01-26 Real-time Process
S003 2004-09-17 135 Review Track For 30-day Notice
S002 2004-08-02 Real-time Process
S001 2004-05-20 Real-time Process

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