Infuse Bone Graft

FDA Premarket Approval P050053 S050

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 NameBone Grafting Material, Dental, With Biologic Component
ApplicantMEDTRONIC Inc.
Date Received2020-06-11
Decision Date2020-07-10
PMAP050053
SupplementS050
Product CodeNPZ 
Advisory CommitteeDental
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address MEDTRONIC Inc. 1800 Pyramid Place memphis, TN 38132

Supplemental Filings

Supplement NumberDateSupplement Type
P050053Original Filing
S050 2020-06-11 30-day Notice
S049 2019-11-04 30-day Notice
S048 2019-10-31 30-day Notice
S047 2019-09-25 30-day Notice
S046
S045
S044 2019-06-28 30-day Notice
S043 2018-10-17 Normal 180 Day Track
S042 2018-10-02 30-day Notice
S041 2018-08-02 30-day Notice
S040 2017-11-13 30-day Notice
S039 2017-05-23 30-day Notice
S038
S037 2017-02-03 30-day Notice
S036 2017-01-23 30-day Notice
S035 2016-06-21 Normal 180 Day Track
S034 2014-10-27 Normal 180 Day Track No User Fee
S033 2014-01-27 Normal 180 Day Track
S032
S031 2013-10-25 Real-time Process
S030 2013-02-26 30-day Notice
S029 2013-01-14 30-day Notice
S028 2012-12-21 30-day Notice
S027
S026 2012-08-21 135 Review Track For 30-day Notice
S025 2012-05-16 Special (immediate Track)
S024 2011-12-19 Normal 180 Day Track
S023 2011-10-04 135 Review Track For 30-day Notice
S022 2011-06-16 135 Review Track For 30-day Notice
S021 2011-02-15 135 Review Track For 30-day Notice
S020 2011-01-13 30-day Notice
S019 2010-09-30 135 Review Track For 30-day Notice
S018 2010-09-30 135 Review Track For 30-day Notice
S017 2010-09-01 Normal 180 Day Track No User Fee
S016 2010-06-03 135 Review Track For 30-day Notice
S015 2010-05-14 Normal 180 Day Track No User Fee
S014
S013 2009-09-01 135 Review Track For 30-day Notice
S012 2009-03-25 135 Review Track For 30-day Notice
S011 2008-12-23 Real-time Process
S010 2008-11-21 135 Review Track For 30-day Notice
S009 2008-08-29 135 Review Track For 30-day Notice
S008 2008-02-19 Normal 180 Day Track
S007 2008-01-18 30-day Notice
S006 2008-01-14 135 Review Track For 30-day Notice
S005 2007-11-06 Normal 180 Day Track No User Fee
S004 2007-07-31 135 Review Track For 30-day Notice
S003
S002 2007-04-06 135 Review Track For 30-day Notice
S001 2007-03-19 Normal 180 Day Track

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