AUGMENT Bone Graft and AUGMENT Injectable
FDA premarket approval P100006/S012 · decided 2021-11-17
Approval details
- PMA number
- P100006
- Supplement
- S012
- Supplement type
- Real-Time Process
- 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
- 2021-09-09
- Decision date
- 2021-11-17
- Days to decision
- 69 days
- Decision code
- APPR
- Product code
- NOX
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Franklin, TN
- Statement
- Approval for use of an alternate cold chain shipping unit, the AeroSafe A50 13L shipper, in addition to the current U39 shipper utilized for AUGMENT Bone Graft and AUGMENT Injectable.
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