PMA P100006S005
- Device
- AUGMENT INJECTABLE
- Applicant
- Biomimetic Therapeutics, LLC
- PMA number
- P100006
- Supplement
- S005
- Product code
- NOX
- Decision date
- 2018-06-12
- Classification
- Filler, Bone Void, Synthetic Peptide
- Generic name
- Filler, bone void, synthetic peptide
- Approval order 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 with preoperative or intraoperative evidence indicating the need for supplemental graft material.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf10/P100006S005B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- AUGMENT INJECTABLE
- Applicant
- Biomimetic Therapeutics, LLC
- PMA number
- P100006
- Supplement
- S005
- Product code
- NOX
- Generic name
- Filler, bone void, synthetic peptide
- Decision date
- 2018-06-12
- Decision code
- APPR
- Date received
- 2016-10-31
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order 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 with preoperative or intraoperative evidence indicating the need for supplemental graft material.