AUGMENT Bone Graft and AUGMENT Injectable
FDA premarket approval P100006/S007 · decided 2019-06-28
Approval details
- PMA number
- P100006
- Supplement
- S007
- 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
- 2018-08-30
- Decision date
- 2019-06-28
- Days to decision
- 302 days
- Decision code
- APPR
- Product code
- NOX
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Franklin, TN
- Statement
- Approval for the following manufacturing sites: Pyramid Laboratories, Inc.3598 Cadillac Avenue Costa Mesa, California 92626 alternate site for the rhPDGF-BB vial tray packagingParter Sterilization Services17115 Kingsview Avenue Carson, California 90746 alternate Ethylene Oxide (EtO) contract sterilizer of finished vial trays
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