Augment® Bone Graft

FDA Premarket Approval P100006 S013

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

DeviceAugment® Bone Graft
Generic NameFiller, Bone Void, Synthetic Peptide
ApplicantBIOMIMETIC THERAPEUTICS,LLC389 Nichol Mill Lnfranklin, TN 37067 PMA NumberP100006 Supplement NumberS013 Date Received12/15/2021 Decision Date06/13/2022 Product Code NOX  Advisory Committee Orthopedic Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Pas Expedited Review Granted? No
Date Received2021-12-15
Decision Date2022-06-13
PMAP100006
SupplementS013
Product CodeNOX 
Advisory CommitteeOrthopedic
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLabeling Change - Pas
Expedited ReviewNo
Combination ProductYes
Applicant AddressBIOMIMETIC THERAPEUTICS,LLC
389 Nichol Mill Ln
franklin, TN 37067 PMA NumberP100006 Supplement NumberS013 Date Received12/15/2021 Decision Date06/13/2022 Product Code NOX  Advisory Committee Orthopedic Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Pas Expedited Review Granted? No Combination ProductYes Approval Order Statement  
Approval For A Modified Package Insert Incorporating Updated Clinical Data Based On Completion Of The Postapproval Clinical Study.

Supplemental Filings

Supplement NumberDateSupplement Type
P100006Original Filing
S013 2021-12-15 Normal 180 Day Track No User Fee
S012 2021-09-09 Real-time Process
S011 2019-11-07 Normal 180 Day Track No User Fee
S010
S009 2019-04-11 Normal 180 Day Track
S008 2018-10-23 Normal 180 Day Track No User Fee
S007
S006 2018-07-02 Real-time Process
S005 2016-10-31 Panel Track
S004 2016-03-21 Normal 180 Day Track No User Fee
S003 2015-09-30 Normal 180 Day Track No User Fee
S002 2015-09-30 Normal 180 Day Track No User Fee
S001 2015-09-28 Real-time Process

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