Infuse Bone Graft

FDA Premarket Approval P000054 S063

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

Introduction of vaccine drug substance protein manufacturing at the dibotermin alfa manufacturing site in pfizer’s andover, ma facility

DeviceInfuse Bone Graft
Generic NameFiller, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction
ApplicantMedtronic Sofamor Danek USA, Inc.
Date Received2020-07-30
Decision Date2020-08-27
PMAP000054
SupplementS063
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
S063 2020-07-30 30-day Notice
S062
S061
S060
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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