- Device
- AUGMENT Bone Graft and AUGMENT Injectable
- Applicant
- Biomimetic Therapeutics, LLC
- PMA number
- P100006
- Supplement
- S012
- Product code
- NOX
- Generic name
- Filler, bone void, synthetic peptide
- Decision date
- 2021-11-17
- Decision code
- APPR
- Date received
- 2021-09-09
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order 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.