AUGMENT Bone Graft and AUGMENT Injectable
FDA premarket approval P100006/S011 · decided 2019-12-06
Approval details
- PMA number
- P100006
- Supplement
- S011
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location 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
- 2019-11-07
- Decision date
- 2019-12-06
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- NOX
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Franklin, TN
- Statement
- Approval for a manufacturing site located at BioMimetic Therapeutics, LLC, 11576 Memphis-Arlington Road, Building C at the Memphis Arlington Campus, Arlington, Tennessee 38002 as an alternate site for product assembly and final kit packaging.
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