PMA P100006S009

Device: AUGMENT Bone Graft and AUGMENT Injectable
Applicant: Biomimetic Therapeutics, LLC
PMA number: P100006
Supplement: S009
Product code: NOX
Decision date: 2019-09-11
Classification: Filler, Bone Void, Synthetic Peptide
Generic name: Filler, bone void, synthetic peptide
Approval order statement: 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.

Current openFDA PMA Record#

Device: AUGMENT Bone Graft and AUGMENT Injectable
Applicant: Biomimetic Therapeutics, LLC
PMA number: P100006
Supplement: S009
Product code: NOX
Generic name: Filler, bone void, synthetic peptide
Decision date: 2019-09-11
Decision code: APPR
Date received: 2019-04-11
Supplement type: Normal 180 Day Track
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: 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.