PMA P100006S004

Device: AUGMENT BONE GRAFT
Applicant: Biomimetic Therapeutics, LLC
PMA number: P100006
Supplement: S004
Product code: NOX
Decision date: 2016-06-23
Classification: Filler, Bone Void, Synthetic Peptide
Generic name: Filler, bone void, synthetic peptide
Approval order statement: Approval for a manufacturing site located at BioMimetic Therapeutics, Inc. (BMTI), 389 Nichol Mill Lane, Franklin, Tennessee, for final kit assembly and packaging.

Current openFDA PMA Record#

Device: AUGMENT BONE GRAFT
Applicant: Biomimetic Therapeutics, LLC
PMA number: P100006
Supplement: S004
Product code: NOX
Generic name: Filler, bone void, synthetic peptide
Decision date: 2016-06-23
Decision code: APPR
Date received: 2016-03-21
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a manufacturing site located at BioMimetic Therapeutics, Inc. (BMTI), 389 Nichol Mill Lane, Franklin, Tennessee, for final kit assembly and packaging.