Augment® Bone Graft
FDA premarket approval P100006/S013 · decided 2022-06-13
Approval details
- PMA number
- P100006
- Supplement
- S013
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Augment® Bone Graft
- Generic name
- Filler, bone void, synthetic peptide
- Applicant
- Biomimetic Therapeutics, LLC
- Date received
- 2021-12-15
- Decision date
- 2022-06-13
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- NOX
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Franklin, TN
- Statement
- Approval for a modified package insert incorporating updated clinical data based on completion of the postapproval clinical study.
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