INFUSE BONE GRAFT

Bone Grafting Material, Dental, With Biologic Component

FDA Premarket Approval P050053 S048

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
Classification NameBone Grafting Material, Dental, With Biologic Component
Generic NameBone Grafting Material, Dental, With Biologic Component
ApplicantMEDTRONIC Inc.
Date Received2019-10-31
Decision Date2019-11-29
PMAP050053
SupplementS048
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
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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