AUGMENT Bone Graft and AUGMENT Injectable

Filler, Bone Void, Synthetic Peptide

FDA Premarket Approval P100006 S009

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 lot uv0023 of the drug substance rhpdgf-bb manufactured by novartis to be used in the manufacture of the drug product used in augment bone graft and augment injectable.

DeviceAUGMENT Bone Graft and AUGMENT Injectable
Classification NameFiller, Bone Void, Synthetic Peptide
Generic NameFiller, Bone Void, Synthetic Peptide
ApplicantBIOMIMETIC THERAPEUTICS,LLC
Date Received2019-04-11
Decision Date2019-09-11
PMAP100006
SupplementS009
Product CodeNOX
Advisory CommitteeOrthopedic
Supplement TypeNormal 180 Day Track
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
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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