AUGMENT Bone Graft and AUGMENT Injectable

FDA Premarket Approval P100006 S012

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

Approval for use of an alternate cold chain shipping unit, the aerosafe a50 13l shipper, in addition to the current u39 shipper utilized for augment bone graft and augment injectable.

DeviceAUGMENT Bone Graft and AUGMENT Injectable
Generic NameFiller, Bone Void, Synthetic Peptide
ApplicantBIOMIMETIC THERAPEUTICS,LLC
Date Received2021-09-09
Decision Date2021-11-17
PMAP100006
SupplementS012
Product CodeNOX 
Advisory CommitteeOrthopedic
Supplement TypeReal-time Process
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address BIOMIMETIC THERAPEUTICS,LLC 389 Nichol Mill Ln franklin, TN 37067

Supplemental Filings

Supplement NumberDateSupplement Type
P100006Original Filing
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

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.