AUGMENT Bone Graft and AUGMENT Injectable
FDA premarket approval P100006/S009 · decided 2019-09-11
Approval details
- PMA number
- P100006
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- AUGMENT Bone Graft and AUGMENT Injectable
- Generic name
- Filler, bone void, synthetic peptide
- Applicant
- Biomimetic Therapeutics, LLC
- Date received
- 2019-04-11
- Decision date
- 2019-09-11
- Days to decision
- 153 days
- Decision code
- APPR
- Product code
- NOX
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Franklin, TN
- 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.
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