INFUSE Bone Graft

FDA Premarket Approval P050053 S056

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

Modification to the cleaning process used in manufacture of the absorbable collagen sponge component of the infuse bone graft product

DeviceINFUSE Bone Graft
Generic NameBone Grafting Material, Dental, With Biologic Component
ApplicantMEDTRONIC Inc.
Date Received2021-03-09
Decision Date2021-04-06
PMAP050053
SupplementS056
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
S059 2022-07-21 30-day Notice
S058 2022-05-10 30-day Notice
S057 2022-01-20 30-day Notice
S056 2021-03-09 30-day Notice
S055 2021-01-15 30-day Notice
S054 2020-07-30 30-day Notice
S053
S052
S051
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.