AUGMENT INJECTABLE
FDA premarket approval P100006/S005 · decided 2018-06-12
Approval details
- PMA number
- P100006
- Supplement
- S005
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- AUGMENT INJECTABLE
- Generic name
- Filler, bone void, synthetic peptide
- Applicant
- Biomimetic Therapeutics, LLC
- Date received
- 2016-10-31
- Decision date
- 2018-06-12
- Days to decision
- 589 days
- Decision code
- APPR
- Product code
- NOX
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Franklin, TN
- Statement
- Approval for AUGMENT Injectable. This combination product is indicated for use as an alternative to autograft in arthrodesis (i.e., surgical fusion procedures) of the ankle (tibiotalar joint) and/or hindfoot (including subtalar, talonavicular, and calcaneocuboid joints, alone or in combination), due to osteoarthritis, post- traumatic arthritis, rheumatoid arthritis, psoriatic arthritis, avascular necrosis, joint instability, joint deformity, congenital defect, or joint arthropathy in patients wi
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