AUGMENT Bone Graft and AUGMENT Injectable
FDA premarket approval P100006/S006 · decided 2018-09-26
Approval details
- PMA number
- P100006
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AUGMENT Bone Graft and AUGMENT Injectable
- Generic name
- Filler, bone void, synthetic peptide
- Applicant
- Biomimetic Therapeutics, LLC
- Date received
- 2018-07-02
- Decision date
- 2018-09-26
- Days to decision
- 86 days
- Decision code
- APPR
- Product code
- NOX
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Franklin, TN
- Statement
- Approval for an alternate secondary packaging configuration for AUGMENT Injectable and corresponding changes in the AUGMENT Injectable package insert and surgical technique guide reflecting this alternate packaging configuration; re-design of the AUGMENT Injectable kit carton to accommodate a pouch in pouch configuration; and modifications to the payload area and the number of frozen gel packs utilized in the approved shipping unit for both AUGMENT Injectable and AUGMENT Bone Graft.
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